AU2006203781A1

AU2006203781A1 - Mobile bearing knee prosthesis

Info

Publication number: AU2006203781A1
Application number: AU2006203781A
Authority: AU
Inventors: Robert Brosnahan; Christopher P Carson; David Evans; Greg Marik; Albert Pothier; Michael Ries
Original assignee: Smith and Nephew Inc
Current assignee: Smith and Nephew Inc
Priority date: 2000-09-26
Filing date: 2006-08-30
Publication date: 2006-09-21
Anticipated expiration: 2021-09-26
Also published as: AU2006203781C1; AU2006203781B2; AU2010214690A1; AU2006203781B8; AU2010214690B2

Description

O AUSTRALIA

O

PATENTS ACT 1990 SDIVISIONAL APPLICATION 00 r- 04 NAME OF APPLICANT: NC Smith Nephew, Inc.

ADDRESS FOR SERVICE: DAVIES COLLISON CAVE Patent Attorneys 1 Nicholson Street Melbourne, 3000.

INVENTION TITLE: "Mobile bearing knee prosthesis" The following statement is a full description of this invention, including the best method of performing it known to us: Q:\OPER\PHH\12184220 30 AUGUST DOC 30/8/06 MOBILE BEARING KNEE PROSTHESIS SThis is a divisional of Australian patent application No. 2001294709, C1 the entire contents of which are incorporated herein by reference.

The present invention relates to orthopaedic prosthetic devices, and more particularly to an improved rotating platform, mobile knee prosthesis that incorporates anterior stabilization along with the ability to constrain the movement of the articular surface from rotation and translation, to rotation 00 only.

IN Femoral rollback is believed to improve range of motion and extensor mechanism leverage so as to improve efficiency and more accurately replicate natural kinematics. Conventional mobile bearing designs may lack the desired effect of femoral rollback, particularly in the absence of the posterior cruciate ligament.

Posterior Stabilized (PS) fixed bearing designs provide femoral rollback by articulating a cam on the femoral component with a post on the tibial articular insert during flexion. However, PS fixed bearing designs do not have the advantages of mobile bearing designs with regards to enhanced range of motion, reduced rehabilitation time, improved patellofemoral alignment, increased contact area, and reduced boneimplant interface shear forces.

In fixed bearing designs, excessive wear of the PS post can occur during articulation with the femoral cam. Internal-external rotation of the femoral component reduces the PS post-femoral can congruency which increases contact stresses. The increased contact stresses can lead to excessive polyethylene wear and component failure. Allowing the PS post to rotate within a fixed articular insert will maintain femoral cam-PS post congruency during internal-external rotation of the femoral component.

Further, in any type of posterior stabilized design (fixed bearing or mobile bearing), one of the most problematic failure modes of the polyethylene is the fracture of the central post of the insert. This failure can O be attributed to "notching" the anterior side of the central post with the anterior most inner-condylar area of the femoral component. Thus, any mechanism to reduce the probability for impingement of the femoral O component against the anterior side of the tibial central post in hyperextension would reduce the probability for tibial insert post failure due to "notching" and ultimately breaking.

00 SPrevious rotating platform designs have incorporated rotating only, or N rotation and translation through the use of different prostheses. An example of a prosthesis that rotates and translates is shown in British publication 2219942, entitled "Knee Prosthesis". US 5,906,643 provides a tibial baseplate with a post that protrudes through a meniscal component and articulates with a cam on a femoral component. The post is an integral part of the tibial baseplate.

US 5,879,392 provides a tibial baseplate with a fixed post that extrudes through the stem of the tibial baseplate and through the bearing component and articulates with a recess within the femoral component.

EP 0916321 A2 provides a femoral component with transverse flanges on the medial and lateral surfaces of the posterior stabilized box that articulates with projections from the medial and lateral surfaces of the post.

WO 95/35484 provides a bearing component with a post that articulates with a recess within the femoral component. The bearing component is limited in rotational, anterior, and posterior movement with respect to the tibial component.

The following patents relate to other orthopaedic prosthetic devices, many of the listed patents pertaining to a knee prosthesis: Patent 3,899,796 4,016,606 4,094,017 4,216,549 4,224,697 4,257,129 4,340,978 4,673,407 4,822,366 4,936,853 4,950,297 4,959,071 5,007,933 5,032,132 5,071,438 5,116,375 5,271,747 5,282,868 5,314,483 5,344,460 5,370,699 5,387,240 Issue Date 08/19/75 04/12/77 06/13/78 08/12/80 09/30/80 03/24/81 07/27/82 06/16/87 04/18/89 06/26/90 08/21/90 09/25/90 04/16/91 07/16/91 12/10/91 05/23/92 12/21/93 02/01/94 05/24/94 09/06/94 12/06/94 02/07/95 Title Metacarpophalangeal Joint Knee Joint Prosthesis Knee Joint Prosthesis with Patellar-Femoral Contact Semi-Stable Total Knee Prosthesis Constrained Prosthetic Knee Prosthetic Knee Joint Tibial Implant New Jersey Meniscal Bearing Knee Replacement Joint-Replacement Prosthetic Device Modular Knee Prosthesis Modular Knee Prosthesis Knee Prosthesis Partially Stabilized Knee Prosthesis Modular Knee Prosthesis System Glenoid Component Tibial Prosthesis With Pivoting Articulating Surface Knee Prosthesis Meniscus Platform for an Artificial Knee Joint Prosthetic Arrangement for a Complex Joint, Especially Knee Joint Meniscus Platform for an Artificial Knee Joint Prosthesis System Modular Knee Joint Prosthesis Floating Bearing Prosthetic Knee 5,395,401 5,404,398 5,413,604 5,413,608 5,549,686 5,609,639 5,658,342 5,702,466 5,782,925 5,871,543 5,871,545 5,935,173 03/07/95 04/11/95 05/09/95 05/09/95 08/27/96 03/11/97 08/19/97 12/30/97 07/21/98 02/16/99 02/16/99 08/10/99 Prosthetic Device for a Complex Joint Prosthetic Knee With Posterior Stabilized Femoral Component Prosthetic Knee Implant for an Anterior Cruciate Ligament Deficient Total Knee Replacement Knee Joint Endoprosthesis for Replacing the Articular Surfaces of the Tibia Knee Prosthesis Having a Tapered Cam Prosthesis for Knee Replacement Stabilized Prosthetic Knee Rotational and Translational Bearing Combination in Biological Joint Replacement Knee Implant Rotational Alignment Apparatus Tibial Prosthesis With Mobile Bearing Member Prosthetic Knee Joint Device Knee Prosthesis The present invention has as an object a tibial prosthesis and mating articular insert with specially configured stabilization posts. The invention enables for the surgeon to convert a mobile bearing articular surface from a fixed to a rotating only or translating only. The prosthesis can also provide rotation and translation simultaneously.

Translation only does not mimic the natural motion of the knee, there however, may be exceptions to the rule. The normal knee translates and rotates. In use of a mobile bearing knee replacement, there are times when the secondary soft tissue structure is compromised so that use of an insert that allows both translation and rotation results in unacceptable instability.

IND

O

O In that case an insert with rotation only is preferred because rotation serves to reduce shear stress at the fixation surface and reduce contact stress at the articular surface, but there is more stability due to the anterioposterior Oconstraint.

In most knee designs rotational malalignment at the articular surface 00 results in a higher contact stress than pure translational malalignment.

0 Rotational freedom has more benefit than translational freedom in reducing 0 the potential for fatigue wear.

These conversions are accomplished with special locking members or plugs that connect to the tibial base special plate. The plugs can be secured to the baseplate with a taper lock or a threaded connection for example.

A post on the proximal tibial base plate can be positioned with an offset with respect to an oval hole in the articular insert to provide anterior stabilization in the total knee prosthesis.

The prosthesis of the present invention will be used as part of a total knee surgery when the surgeon chooses to use a prosthesis that incorporates a particular, selected relative motion between tibial tray and tibial insert.

This present invention consists of a posterior stabilized PS post which is secured to the mobile bearing tibial baseplate allowing only rotational movement. The PS post captures a bearing component to the tibial baseplate through an elongated slot in the bearing component. The elongated slot in the bearing component allows it to translate anteriorly and posteriorly with respect to the posterior stabilized post. The bearing component may also rotate with respect to the tibial baseplate in conjunction with the PS post. The bearing component has two concave O surfaces that are articulate with the convex surfaces of the femoral component, and that are roughly congruent with the convex surfaces of the ;femoral component at zero degrees of flexion or full extension. The PS 0 post articulates with a recess or cam of the femoral component to provide femoral rollback.

00 In addition to the above described design, the PS post should allow Sfor posterior translation, in addition to rotational movement. This posterior N movement would allow the post to translate instead of impinging upon the inner-condylar notch area of the femoral component in hyper-extension.

The PS post has a flat distal surface that articulates with the tibial baseplate. A T-slot is located on the distal end and articulates with a T-post on the tibial baseplate. A through hole in the PS post is located such that a rotation peg can capture the PS post to the tibial baseplate while the T-slot of the PS is engaged with the T-post of the tibial baseplate. The rotation peg allows only rotational freedom of the PS post with respect to the tibial baseplate. The PS post has a flange on the medial and lateral surfaces that capture the bearing component through a counterbore on the medial and lateral sides of an elongated slot of the bearing component. The elongated slot of the bearing component is larger than the PS post in the anterior-posterior direction such that the bearing component has limited translational with respect to the PS post. The bearing component may also rotate with respect to the tibial baseplate in conjunction with the PS post.

The bearing component has two concave surfaces that are congruent to the convex surfaces of the femoral component. A cam mechanism on the femoral component can be a concave cylinder that can be congruent to the convex posterior surface of the PS post. The internal/external rotation of the PS post with the femoral component can maintain this congruency throughout the range of motion unlike designs with a fixed PS post.

O The addition of the posterior translation can occur with an anterior to posterior slot instead of a hole as seen in the inferior view above.

This slot would allow for posterior translation of the post relative to the Oinsert/baseplate.

The PS post may engage the tibial baseplate through a pin means or 00oo through a boss of a configuration other than a T-post. The PS post may 0 secure the bearing component through the use of slots or other means of

(N

N capture. The PS post may articulate with a closed recess within the femoral component rather than a cam mechanism.

With the fixed bearing design, the means of PS post capture may be with the use of a retaining ring or a cross pin. The PS post may not require capture with the fixed bearing articular insert.

The present invention also provides an improved knee prosthesis apparatus that includes a tibial prosthesis that is configured to be surgically implanted on a patient's transversely cut proximal tibia and a femoral component. The femoral component articulate with a tibial insert having a proximal surface that engages the femoral component, the insert having a distal surface that fits against and articulates with the proximal surface of the tibial prosthesis.

A constraining mechanism joins the tibial insert to the tibial prosthesis in a selective fashion that enables a number of different possible relative motions between the insert and the tibial prosthesis, including anterior to posterior translation with rotation, or rotation only.

All or part of the constraining mechanism is separable from the tibial prosthesis, and selective removal of all or part of the constraining mechanism determines which of the said possible relative motions will take place.

b The tibial prosthesis can have a fixator for holding the tibial prosthesis on a patient's proximal tibia such as for example, a stem, spike, cement, O etc.

The proximal surface of the insert can have one or more concavities 00 for articulating with the femoral component.

N The femoral component can include an intercondylar surface that is positioned to contact the post, enabling relative motion between the femoral component and the insert to be constrained.

According to the present invention there is provided a knee prosthesis apparatus comprising: a) a tibial component configured to be surgically implanted on a patient's transversely cut proximal tibia; b) a femoral component; c) a fixator for holding the tibial component on the patient's proximal tibia; d) a tibial insert having a proximal surface that is shaped to engage the femoral component, the insert having a distal surface that fits against and articulates with the proximal surface of the tibial component; e) a constraining mechanism that joins the tibial insert to the tibial component in a selective fashion that enables a number of different possible relative motions between the insert and tibial component including anterior to posterior translation with rotation, or rotation only; and f) wherein all or part of the constraining mechanism is separate from the tibial components and selective removal of all or part of the constraining mechanism will take place.

Also according to the present invention there is provide a knee prosthesis for replacing all or part of a patient's knee joint at the joint between the patient's femur and tibia, comprising: a) a tibial component adapted to be surgically implanted on a patient's transversely cur proximal tibia; b) a fixator for holding the tibial component on the patient's proximal 6 tibia; c) a tibial insert having a distal surface that fits against and articulates with the proximal surface of the tibial component and a proximal femoral ;articulating surface; d) a femoral component that articulates with the tibial 0 prosthesis at the proximal articulating surface of the tibial insert, the tibial insert having condylar surfaces that engage but not substantially constrain the condylar surfaces of the femoral component; e) a constraining 00 mechanism that enables a selective connection to be made between the Sinsert to the tibial component during use, to thereby define a number of relative motions between the tibial component and the tibial insert including 0 10 rotation only or anterior to posterior translation or anterior to posterior translation coupled with rotation; and f) wherein the constraining mechanism includes a removable locking member that is connectable to or disconnectable from the tibial component, wherein the insert is further constrained relative to the tibial component when the removable locking member is connected to the tibial component.

In a further embodiment of the present invention there is provided a knee prosthesis apparatus comprising: a) a tibial component including a tibial tray portion configured to be surgically implanted on a patient's transversely cut proximal tibia; b) a fixator for holding the tibial component on the patient's proximal tibia; c) a tibia insert having first and second removably connectable members, including a peripheral member having a central opening and a central member that connects to the central opening the insert having a distal surface that fits against and articulates with the proximal surface of the tibial component; d) a femoral component; e) a constraining mechanism that joins the insert to the tibial tray portion during use in a selective fashion that enables a number of different possible relative motions between the insert and tibial tray including anterior to posterior translation and rotation or rotation only; and f) wherein all or part of the constraining mechanism is separate from the tray and selective O removal of all or part of the constraining mechanism determines which of the said possible relative motions will take place.

OFor knee flexion to be optimized, the femur must roll back on the tibia.

This means that the contact point between the femoral and tibial components moves posteriorly. In a one-piece mobile bearing PS design, 00 roll back is caused by the contact of the bar of the femoral component on athe post of the tibial insert. This contact tends to push the insert forward IN (relative to the tibia). In order for normal roll back (with respect to the tibia) 0 10 to occur, the bar and post design must compensate by causing the femur to roll back on the surface of the tibial insert (the contact point moves posteriorly on the insert). Movement of the contact point causes the stress levels to fluctuate and can lead to fatigue and adhesive wear of the polyethylene.

In a two piece tibial insert design, the post does not translate, but the insert does. This allows the insert to move posteriorly with the femoral component as the bar/post interaction dictates. However, since the insert moves with the femoral component, the contact point does not move posteriorly on the tibial insert. This provides a more consistent stress level and reduces the tendency for fatigue and adhesive wear.

For a further understanding of the nature, objects, and advantages of the present invention, reference should be had to the following detailed description, read in conjunction with the following drawings, wherein like reference numerals denote like elements and wherein: Fig. 1 is a perspective, exploded view of the preferred embodiment of the apparatus of the present invention; Fig. 2 is a partial sectional of the preferred embodiment of the apparatus of the present invention illustrating the locking member portion thereof; 0 Fig. 3 is a top, fragmentary view of the preferred embodiment of the tapparatus of the present invention illustrating the locking member portion ;thereof; OFig. 4 is a partial, elevational view of the preferred embodiment of the apparatus of the present invention illustrating the locking member portion thereof; 00 Fig. 5 is a rear, elevational and exploded view of the preferred Sembodiment of the apparatus of the present invention illustrating the N articular polymeric insert and tray portions thereof; 0 S 10 Fig. 6 is a sectional, elevational view of the preferred embodiment of the apparatus of the present invention shown with the locking member removed; Fig. 7 is another sectional, elevational view of the preferred embodiment of the apparatus of the present invention illustrating the locking member in operating position when only rotational movement is desired; Fig. 8 is a partial top view of the preferred embodiment of the apparatus of the present invention showing the polymeric insert; Fig. 9 is a partial, bottom view of the preferred embodiment of the apparatus of the present invention showing the polymeric insert; Fig. 10 is partial rear view of the preferred embodiment of the apparatus of the present invention showing the polymeric insert; Fig. 11 is a partial sectional view of the preferred embodiment of the apparatus of the present invention taken along lines 11-11 of Fig.8; Fig. 12 is a sectional view of the preferred embodiment of the apparatus of the present invention taken along lines 12-12 of Fig. 8; Fig. 13 is a partial top view of the preferred embodiment of the apparatus of the present invention illustrating the tray or baseplate; Fig. 14 is a sectional view of the preferred embodiment of the apparatus of the present invention taken along lines 14-14 of Fig. 13; Fig. 15 is a top view of the preferred embodiment of the apparatus of the present invention illustrating the insert and tray portions thereof in operating position with the locking member; O Fig. 16 is a top side view of the preferred embodiment of the apparatus of the present invention illustrating the insert, tray and locking ;member portions thereof in operating position; 0 Fig. 17 is a top view of the preferred embodiment of the apparatus of the present invention illustrating rotation of the insert relative to the tray; Figs. 18 21 are fragmentary perspective views of an alternate 00oo embodiment of the apparatus of the present invention illustrating 0 constructions for the post portion and illustrating the connection between N the post and the tray; Figs. 22 25 are schematic plan views of alternate constructions of the tibial insert to be used respectively with the post constructions of Figs.

18 -21; Fig. 26 is a top view of the second alternate embodiment of the apparatus of the present invention illustrating the tray portion thereof; Fig. 27 is an elevational view of the second alternate embodiment of the apparatus of the present invention illustrating the tray portion thereof; Fig. 28 is a bottom view of the second alternate embodiment of the apparatus of the present invention illustrating the tray portion thereof; Fig. 29 is a plan view of the second embodiment of the apparatus of the present invention illustrating the polymeric insert portions thereof; Fig. 30 is a frontal elevational view of the second alternate embodiment of the apparatus of the present invention illustrating the plastic insert portion thereof; Fig. 31 is a bottom view of the plastic insert portion of the second alternate embodiment of the apparatus of the present invention; Fig. 32 is a fragmentary view of the second alternate embodiment illustrating the locking plug member portions thereof; Fig. 33 is a sectional view taken along lines 33 33 of Fig. 32; Fig. 34 is a sectional view taken along lines 34 34 of Fig. 26; Fig. 35 is a sectional view taken along lines 35 35 of Fig. 29; Fig. 36 is a sectional view taken along lines 36 36 of Fig. 29; SFig. 37 is an elevational view of the second alternate embodiment of the apparatus of the present invention illustrating the cap and set screw ;separated from the insert and tray portions thereof; 0 Fig. 38 is a partial sectional elevational view of the second alternate embodiment of the apparatus of the present invention illustrating the mobile _insert moving with respect to the tray; 00 Fig. 39 is a perspective exploded view of a third alternate embodiment aof the apparatus of the present invention; I Fig. 40 is a partial top view of the third alternate embodiment of the 0 0 10 apparatus of the present invention illustrating the insert portion thereof; Fig. 41 is a side view of the insert portion of the third alternate embodiment of the apparatus of the present invention; Fig. 42 is a perspective view of the insert portion of the third alternate embodiment of the apparatus of the present invention; Fig. 43 is a posterior view of the insert portion of the third alternate embodiment of the apparatus of the present invention; Fig. 44 is a bottom view of the tray portion of the third alternate embodiment of the apparatus of the present invention; Fig. 45 is a side view of the tray portion of the third alternate embodiment of the apparatus of the present invention; Fig. 46 is a perspective view of the tray portion of the third alternate embodiment of the apparatus of the present invention; Fig. 47 is a posterior view of the tray portion of the third alternate embodiment of the apparatus of the present invention; Figs. 48 49 are fragmentary views of the third alternate embodiment of the apparatus of the present invention illustrating one of the plug portions thereof; Figs. 50 -51 are side and top views of a second plug portion that is used with the third alternate embodiment of the apparatus of the present invention; Fig. 52 is a perspective, exploded view of a fourth alternative embodiment of the apparatus of the present invention; SFig. 53 is a sectional, elevational view of the fourth alternative embodiment shown in Fig. 52, shown with the locking member removed; Fig. 54 is another sectional, elevational view of the fourth alternative O embodiment shown in Fig. 52, illustrating the locking member in operating position when only rotational movement is desired; Fig. 55 is a partial top view of the fourth alternative embodiment of the 00 apparatus shown in Fig. 52 illustrating the tray; Fig. 56 is a sectional view of the fourth alternative embodiment of the N apparatus shown in Fig. 52 taken along lines 56 56 of Fig. Fig. 57 is a perspective view of a fifth alternate embodiment of the apparatus of the present invention; Fig. 58 is a side, elevational view of a fifth alternate embodiment of the apparatus of the present invention; Fig. 59 is a posterior elevation view of a fifth alternate embodiment of the apparatus of the present invention; Fig. 60 is a side elevation view of a fifth alternate embodiment of the apparatus of the present invention showing the knee in an extended position; Fig. 61 is a side elevation view of a fifth alternate embodiment of the apparatus of the present invention showing the knee in a flexed position; Fig. 62 is a fragmentary anterior elevation view of a fifth alternate embodiment of the apparatus of the present invention showing polymeric insert; Fig. 63 is a fragmentary posterior elevation view of a fifth alternate embodiment of the apparatus of the present invention showing polymeric insert; Fig. 64 is a fragmentary side sectional elevation view of a fifth alternate embodiment of the apparatus of the present invention showing polymeric insert; Fig. 65 is a fragmentary plan view of a fifth alternate embodiment of the apparatus of the present invention showing polymeric insert; O Fig. 66 is a fragmentary bottom view of a fifth alternate embodiment of the apparatus of the present invention showing polymeric insert; ;Fig. 67 is a fragmentary perspective view of a fifth alternate 0 embodiment of the apparatus of the present invention showing polymeric insert; Fig. 68 is a top view of the fifth alternate embodiment of the apparatus 00oo of the present invention; SFig. 69 is a top view of the sixth alternate embodiment of the N apparatus of the present invention; S 10 Fig. 70 is a fragmentary bottom view of the sixth alternate embodiment of the apparatus of the present invention showing one of the polymeric insert portions; Fig. 71 is a fragmentary top view of the sixth alternate embodiment of the apparatus of the present invention showing one of the polymeric insert portions; Fig. 72 is a fragmentary frontal elevation view of the sixth alternate embodiment of the apparatus of the present invention showing one of the polymeric insert portions; Fig. 73 is a fragmentary rear elevation view of the sixth alternate embodiment of the apparatus of the present invention showing one of the polymeric insert portions; Fig. 74 is a fragmentary side sectional elevation view of the sixth alternate embodiment of the apparatus of the present invention showing one of the polymeric insert portions; Fig. 75 is a fragmentary perspective view of the sixth alternate embodiment of the apparatus of the present invention showing one of the polymeric insert portions; Fig. 76 is a side elevation view of the sixth alternate embodiment of the apparatus of the present invention illustrating one of the polymeric insert portions; 6 Fig. 77 is a fragmentary rear elevation view of the sixth alternate embodiment of the apparatus of the present invention illustrating one of the polymeric insert portions; OFig. 78 is a fragmentary bottom elevation view of the sixth alternate embodiment of the apparatus of the present invention illustrating one of the polymeric insert portions; 00 Fig. 79 is a fragmentary frontal elevation view of the sixth alternate Sembodiment of the apparatus of the present invention illustrating one of the N polymeric insert portions; S 10 Fig. 80 is a fragmentary plan view of the sixth alternate embodiment of the apparatus of the present invention illustrating one of the polymeric insert portions; Fig. 81 is a fragmentary perspective view of the sixth alternate embodiment of the apparatus of the present invention illustrating one of the polymeric insert portions; Figs. 1 -7 show generally the preferred embodiment of the apparatus of the present invention designated generally by the numeral 10 in Figs. 1, 6 and 7.

Mobile bearing knee prosthesis (10) is placed upon a patient's surgically cut proximal tibia (11) at a surgically cut proximal surface (12) that is preferably flat. This enables a tray (13) to be mounted to the proximal tibia (11) at surface (12) as shown in Figs. 6 7. Tray (13) has a flat proximal surface (14) and a generally flat distal surface (15) that mates with and faces the surgically prepared surface (12) as shown in Figs. 6 7.

The tray (13) can provide a plurality of spikes (16) and a stem (17) for enhancing implantation to the patient's proximal tibia However, any other known attachment can be used to affix tray (13) to a patient's proximal tibia such as chemical element) or mechanical fasteners (fastener).

II

O The proximal surface (14) of tray (13) provides a post (18) having an tinternally threaded socket Post (18) is comprised of a generally ;cylindrically-shaped smaller diameter section (20) and an enlarged flange O(21) that mounts to the top of cylindrically-shaped (20) as shown in Figs. and 13-14. Tray (13) has periphery A recess (23) is provided in between the proximal surface (14) of tray (13) and flange (21).

00 OA locking member (24) forms a removable connection with the socket I Locking member (24) has an externally cylindrical section (25) that 0 0 10 provides threads that correspond to the threads of internally threaded socket (19) so that the locking member (24) can be threaded into the socket (19) as shown in Fig. 7. Locking member (24) includes an enlarged cylindrically-shaped head (26) having a tool receptive socket (27) such as a hexagonal socket for example.

An insert (28) provides a vertical channel (33) that can be placed in communication with post (18) as shown in Figs. 6 7. Insert (28) provides a preferably flat distal surface (29) that communicates with the flat proximal surface (14) of tray A pair of spaced apart concavities (30, 31) are provided for defining articulation surfaces that cooperate with correspondingly shaped articulating surface on a patient's femur or femoral implant. The insert (28) has a periphery (32) that generally corresponds in shape to the periphery (22) of tray Insert (28) can be polymeric or metallic or of a composite construction, such as metallic with a polymeric articulating surface(s) or polymeric with a metallic articulating surface(s).

Vertical channel (33) is comprised of a number of sections that are specially shaped to interact with the post (18) and locking member (24).

Vertical channel (33) thus includes a proximal, cylindrically-shaped section an oval shaped slot and a distal opening The distal opening (36) includes a generally oval section (37) and a somewhat half oval section The oval section (38) can track any of three directions I18

O

0 including a pure anterior to posterior direction, a direction that is at an angle tb2 to a pure anterior to posterior direction; or a direction that is an arcuate or curved path that pivots or rates about a point that is not located along the OA/P centreline of the insert. Flat surfaces (39, 40) are positioned at the top of and at the bottom of the oval shaped slot (35) as best seen in Figs 8 11. The cylindrically-shaped head (26) of locking member (24) closely fits 00 the cylindrically-shaped section (36).

n order to assemble insert (28) to tray the distal surface of (29) of insert (28) is placed next to and generally parallel to the proximal surface (14) of tray Post (18) is aligned with vertical channel (33) of insert During assembly of insert (28) to tray the post (18) is shaped to enter the oval opening portion (37) of distal opening Once the distal surface (29) of insert (28) meets proximal surface (14) of tray flange (21) aligns with oval shaped slot (35) of vertical channel After such assembly, insert (28) is held in position by post This retention of insert (28) by post (18) occurs when flange (21) engages flat surface (40) to prevent separation if any rotation (see arrow (41) of Fig. 17) at all occurs between insert (28) and tray if no rotation has occurred between insert (28) and tray (13) (see Fig. 15), the oval shaped circular section (37) is sized to allow post (18) to be inserted into or withdrawn from channel (33).

In Fig. 15, the apparatus (10) is shown in an assembled position wherein the fastener (24) has been removed so that the insert (28) can move in a translation and rotation and rotation fashion relative to tray (13).

In Fig. 16, the fastener (24) has been threadably attached to the internally threaded socket (19) and is in operating position. In Fig. 17, the insert (28) can rotate relative to the tray (13) through an angle However, because of the attachment of fastener only rotation and not translation is permitted in Fig. 17. Thus, in Fig. 17, the apparatus (10) of the present invention provides a mating mechanism between post (18) and the fastener O (24) and the insert (28) that defines a constraining mechanism so that the tinsert (28) may be constrained for rotation only relative to the tray (13).

OIn Figs. 18 21 and 22 25, there is seen various alternate constructions of the post that can be used instead of post 18 when the selected post is fitted to the tibial tray In Figs. 22 25, an alternate 00 construction of the insert (28) is shown with an illustration of the various Stypes of relative motion between the insert and the tibial tray that can be selectively provided to a surgeon.

O In Figs. 18 21, four different constructions of the post are provided.

In Fig. 18, a post (42) has a cylindrical outer surface (43) and a circular top Post (42) has a rectangular base (45) with a generally flat undersurface and a plurality of four inclined surfaces (46) which provides a means of attaching the post to the tray or the post may be permanently attached to the tray. The rectangular base (45) fits tray (13A) socket (47) at its inclied surfaces (48) with a taper lock type connection for example.

Other types of connections could be used to join post (42) to tray (13A) at socket (47).

In Fig. 19, post (49) includes a plurality of four vertical side walls and a plurality of inclined surfaces A rectangular flat top (52) is provided opposite a generally flat undersurface of post The inclined surfaces (51) of post (49) fit similarly configured inclined surfaces (48) of socket (47) in tray (13A).

In Fig. 20, post (53) is generally rectangularly shaped providing a pair of opposed flat larger vertical side walls (54) and a pair of opposed flat smaller end walls (55) with a flat top Post (53) has a base (57) that includes four inclined surfaces The inclined surfaces (58) form a taper lock connection with four similarly configured inclined surfaces (48) of socket (47) of tray (13A).

tIn Fig. 21, post (59) has a hexagonal shape providing a hexagonally ;shaped flat top Hexagonal post (59) also has a plurality of vertical O side walls (61) and a rectangular base The base (62) has inclined surfaces (63) that form a taper lock connection with inclined surfaces (48) of tray socket (47) of tray (13A).

00 SIn Fig. 22, insert (28A) provides a square opening (64) that exactly fits N peg In Fig. 22, there is no relative motion between insert (28A) and 0 0 10 tray (13A). In Fig. 23, rotational motion only is indicated by arrow between insert (28A) and tray (13A) when peg (42) is used.

In Fig. 24, the rectangular peg (53) enables only translational movement between the insert (28A) and tray (13A) as indicated by arrow In Fig. 25, the hexagonal peg (59) enables both rotational motion as indicated by arrow (65) and translational motion as indicated by arrow (66) between insert (28A) and tray (13A).

An alternate embodiment of mobile bearing knee apparatus (110) is shown generally in Fig. 37. In Fig. 37, the prosthesis (110) is shown positioned upon a patient's proximal tibia (111), specifically upon a flat surgically cut proximal surface (112) as shown.

In Figs. 26 28, tibial tray (113) is shown, which can be of metallic construction such as titanium alloy, for example. Tray (113) has a flat proximal surface (114) and a flat distal surface (115). A plurality of mechanical fasteners such as spikes (116) on surface (115) can be used to enhance fixation of tibial tray (113) to the patient's proximal tibial (111).

Chemical fasteners cement) can also be used for fixation. A stem (117) can also be used to facilitate attachment of prosthesis (110) to the patient's tibia (111) at the tibial intramedually canal.

INDI

O The flat proximal surface (114) of tray (113) has a round post (118) with a hollow bore or socket (119). The post (118) is spaced inwardly from the periphery (120) of tray (113) as shown in Figs. 26 27. The post (118) Ois preferably positioned with an offset with respect to oval slot (126) in the articular insert to provide anterior stabilization in the total knee prosthesis.

o00 Figs. 29 31 show the insert (121) portion of the present invention, typically a polymeric plastic insert that fits tray (113). Insert (121) has a flat IND distal surface (122) and a proximal surface (123) that includes curved portions. These curved portions are in the form of concavities (124, 125) receive shaped surfaces of a femoral prosthesis after total knee replacement surgery is completed. The flat distal surface (122) of insert (121) has an anterior to posterior extending generally oval shaped slot (126) as shown in Fig. 31.

The slot (126) receives post (118) during use, enabling the insert (121) to slide in an anterior to posterior direction relative to tray (113).

The present invention provides a rotating platform, mobile knee prosthesis (110) that incorporates anterior stabilization along with the ability to selectively constrain the movement of he articular surface from rotation and translation to rotation only. This is accomplished by using an opening (136) in insert (121) that communicates with slot (126) as shown in Figs. 29 -31 and 35 38. The opening includes a frustoconical portion (137) that corresponds in shape to a similar frustoconically-shaped enlarged annular surface (134) of locking plug member (127). The locking plug member (127) is shown more particularly in Figs. 32 33 and 37.

Locking plug member (127) includes a lower frustoconical surface (128). The frustoconical outer surface (128) of locking member (127) below annular reference line (138) is sized and shaped to fit and form a taper lock connection with surface (139) of frustoconical socket (119) of post (118).

6 Above annular reference line (138), the enlarged annular should has a frustoconical shape as shown in Fig. 32 that corresponds generally to the ;size and shape of frustoconical portion (137) of opening (136) as shown in 0 Fig. 36.

_When the locking member (127) is first placed through opening (136) 00 of insert (121) and then into frustoconical socket (119) of post (118), a Slocking connection is formed between the frustoconical outer surface (128) N of locking member (127) and the frustoconical surface (139) of post (118).

This connection can be a taper lock type connection.

Locking screw (131) can be used to engage a correspondingly sized and shaped internally threaded opening (132) of tray (113) if desired. The locking screw (131) can include a head (140) that is enlarged so that the head (140) is retained by annular should (133) of locking member (137) as shown in Figs. 33 and 37.

In Fig. 38, arrows (141) indicate sliding movement of insert (121) relative to tray (113) as occurs when locking plug member (127) is removed. In such a situation, the insert (121) is free with respect to tray (113). The distal surface (122) of insert (121) slides upon the flat proximal surface (114) of tray (113). Post (118) slides relative to slot (126).

When locking member (127) is inserted through opening (136) and into socket (119) of post (118), sliding movement is prevented. The enlarged annular (134) of locking member (127) engages the frustoconical portion (137) of opening (136) disallowing a sliding action of insert (121) relative to tray (113). However, the enlarged annular shoulder (134) of locking member (127) is slightly spaced from frustoconical portion (137) of opening (136), so that rotational movement of insert (121) relative to tray (113) is permitted. The second alternate embodiment of the present invention provides a rotating platform, mobile knee prosthesis (110) that O incorporates anterior stabilization along with the ability to constrain movement of the articular surface from rotation and translation to rotation only.

Figs. 39 and 40 51 show a third alternate embodiment of the apparatus of the present invention designated generally by the numeral 142 00 r- in Fig. 39. Mobile bearing knee prosthesis (142) includes a tray (143) that acan be attached to a patient's surgically cut proximal tibia using a stem N (146) for example that occupies the patient's intramedullary canal. The tray 0 10 (143) has a proximal surface (144) that receives an insert (159) and a distal surface (145) that registers upon the proximal tibia after the tibia has been surgically prepared to conform to the underside or distal surface (145) of tray (143).

The proximal (144) surface of tray (143) provides a frustoconicallyshaped socket (147) that can receive either of two selected plugs (148 or 154) (or any of the plug embodiments shown in Figs. 18 21). The first plug (148) is designed to provide rotational movement only between insert (159) and tray (143). The plug (148) has a frustoconical surface (149), cylindrical surface (150), bevelled annular surface (151), and a pair of opposed generally parallel flat end surfaces (152, 153).

The second plug (154) is designed to provide both anterior to posterior translational movement between the insert (159) and tray (153) as well as rotational movement between the insert (159) and tray (153). The plug (154) has a frustoconical surface (155), a reduced diameter cylindrical surface (156), and flat end surfaces (157, 158).

During use, a surgeon selects either of the plugs (148 or 154). The frustoconical surfaces (149 or 155) form a tight taper lock fit with a correspondingly shaped frustoconical socket (147) that communicates with the proximal (144) surface of tray (143). Once the selected plug (148 or 0 154) has been inserted into frustoconical socket (147), the insert (159) is placed on the selected plug (148 or 154). The shape of the plug (148 or ;154) that is selected determines whether or not the insert (159) can achieve Oonly rotational movement relative to tray (143) or both rotational and anterior to posterior translational movement.

00 In the case of the plug (148), only rotational movement between the Sinsert (159) and the tray (143) can be attained. The plug (148) is shorter N and thus only communicates with the cylindrically-shaped opening (164) on the bottom or distal surface (162) of insert (159). Plug (148) once inserted in socket (147) only enables a rotational movement of the insert (159) on the tray (143). The cylindrical surface (150) of plug (148) corresponds in size and shape to the circular opening (164) to accomplish a relatively close fit between cylindrical surface (150) of plug (148) and cylindrical opening (164) on insert (159).

When both rotational and translational anterior to posterior movement are desired, the surgeon selects the plug (154). The plug (154) is placed in socket (147) so that frustoconical surface (155) forms a taper lock fit with a correspondingly sized and shaped socket (147) of tray (143). The smaller cylindrically-shaped portion (156) of plug (154) is taller in a proximal to distal direction than the cylindrically-shape portion (150) of plug (148). The portion (156) fits elongated slot (163) so that the insert (159) can translate in an anterior to posterior direction as the reduced diameter cylindrical portion (156) travels anterior to posterior in the direction of arrow (165) in Fig. 44. However, the insert can also translate along the path (165) that curved, or along a path (165) that forms an angle with a purely anterior to posterior direction line. The line (165) in Fig. 44 shows such a purely anterior to posterior line as the direction of travel. Because the slot (163) is at least as wide as the diameter of cylindrical portion (156) and tray (143).

Insert (159) also provides proximal concavities (160, 161) for receiving a femoral component of a knee implant.

Figs. 52 56 disclose a fourth alternate embodiment of this invention identified as prosthesis (210), comprising a tibial tray (213), a polymeric Oinsert and a locking member In this embodiment, insert (28) and locking member (24) are the same as described above, but flange (221) is generally D-shaped, having a periphery extending laterally in the medial, 00 lateral, and anterior directions from the out surface of cylindrical section S(220), thereby creating recess (223) on the medial, lateral and anterior N sides of section (220) (see Figs. 55 56). As evidenced by the following description, the assembly of prosthesis (210) is essentially identical to that of prosthesis (10) except for the shape of flange (221).

Locking member (24) forms a removable connection with the socket (219). Locking member (24) has an externally cylindrical section (25) that provides threads that correspond to the threads of internally socket (219) so that the locking member (24) can be threaded into the socket (219) as shown in Fig. 54.

In order to assemble insert (28) to tray (213), the distal surface (29) of insert (28) is placed next to and generally parallel to the proximal surface (214) of tray (213). Post (218) is aligned with vertical channel (33) of insert During assembly of insert (28) to tray (213), the post (218) is oriented to enter the oval opening portion (37) of distal opening Once the distal surface (29) of insert (28) meets proximal surface (214) of tray (213), flange (221) aligns with oval shaped slot (35) of vertical channel After such assembly, insert (28) is held in position by post (218). This retention of insert (228) by post (218) occurs when flange (221) engages flat surface to prevent separation if any rotation at all occurs between insert (28) and tray (213). If no rotation has occurred between insert (28) and tray (213), the oval shaped circular section (37) is sized to allow post (218) to be inserted into or withdrawn from channel (33).

O Figs. 57 67 show a fifth alternate embodiment of the apparatus of the present invention designated generally by the numeral 200 in Figs. 57 61.

;It should be understood that the embodiment of Figs. 57 61 disclose an 0 alternate construction for a polymeric insert (202) that interconnects with the same tibial tray (13) and stem (17) shown in Figs. 1, 5 7 and 14 16 of the preferred embodiment. In Figs. 57 59, mobile bearing knee oo 00 prosthesis (200) is shown as including tray polymeric insert (202), and afemoral component (236). In Fig. 58, the femoral component (236) is IND shown attached to a patient's surgically cut distal demur (201).

0 Polymeric insert (202) (see Figs. 62-67) has a flat distal surface (203) and a proximal surface with a pair of concavities (204, 205). Insert (202) also has periphery (206) and vertical channel (207). The vertical channel (207) can be a slotted arrangement such as that shown in the preferred embodiment of Figs. 1 17 and designated generally by the numeral 33.

Thus, the connection between post (18) of tray (13) and insert (202) can be the same connection that is shown and described with respect to the preferred embodiment of Figs. 1 -17 and shown particularly in Figs. 1 7 and 15 17, or as shown in Figs. 52 -56.

Vertical channel (207) can include a proximal cylindrically-shaped section (208), an oval shaped slot (209), and a distal opening (224). The distal opening (224) can include an oval section (226) and a half oval section (227) as shown in Fig. 66. Flat surface (225) extends posteriorly of vertical channel (207) more particularly posteriorly of the proximal cylindrically-shaped section (208), as shown in Figs. 64 65. Flat surfaces (228, 229) register with the flange (21) of post respectively above and below the flange (21) to thereby prevent separation of polymeric insert (202) from post (18) unless the post (18) is aligned with oval section (226) of distal opening (224). When the flange (21) of post (18) aligns with oval section (226) of distal opening (224), insert (202) can be separated from tray (13).

tIn the embodiment of Figs. 57 68, insert (202) provides a central ;post (230). Post (230) has proximal surface (231), anterior surface (232), O posterior surface (233), and sides (234, 235).

Femoral component (236) is shown in Figs. 57 -61. Femoral 00 component (236) has anterior portion (237), a pair of posterior condylar portions (238, 239) and distal condylar portions (240, 241). Femoral N component (236) has central opening (242) and a horizontal bar cam (243) that extends between posterior condylar portions (238, 239) as best seen in Figs. 59 and 68. A pair of vertical walls (244, 245) extend along opposing sides of central opening (242) and connect to both of the posterior condylar portions (238, 239) and to horizontal bar (243). The vertical walls (230, 231) also extend to and connect to surfaces (248, 249, 250). The vertical walls (244, 245) can be generally parallel.

Femoral component (236) provides a plurality of flat surfaces that register against and conform to surgically cut flat surfaces that are provided on the patient's distal femur (201) as shown in Fig. 58. These flat surfaces include flat surface (246) is an anterior surface, surface (247) which is a diagonally extending anterior surface that spans between anterior surface (246) and distal surface (248). Distal surface (248) spans between diagonal surface (247) and posterior diagonal surface (249). Posterior surface (250) is generally parallel to anterior flat surface (246). These five flat surfaces (246 250) of femoral component (236) register against and conform to five surgically cut surfaces on a patient's distal femur (201).

Femoral component (236) can be securely fashioned to the patient's femur (201) using bone cement for example.

In Figs. 60 61, a range of motion for the patient's knee fitted with mobile bearing knee prosthesis (200) as illustrated with arrows (252, 253).

For purpose of reference, the patient's central longitudinal axis (251) of the O distal femur (201) is shown rotating posteriorly in the direction of arrow (253). The anterior surface (237) of femoral component (236) is shown rotating in the direction of arrow (252). Fig. 60 shows an extended position Cof the patient's knee wherein the longitudinal axis (251) of the femur (201) is generally aligned with the central longitudinal axis of the patient's tibia In Fig. 61, the knee is shown in a flexed position. In this position, 00 horizontal bar cam (243) of femoral component (222) registers against the aposterior surface (233) of central post (230) of polymeric insert (202). In N this position, the central post (230) causes femoral roll back on the tibia 0 10 articular insert (202). The posterior aspect of the tibia articular surface at (233) provides a lift that is created by generally following the curvature of the femoral component (236) in extension. This will provide a high degree of surface contact, conformity, subsequently providing low contact stress, in extension, where most of gait occurs. The post (230) can have a square or rectangular base that fits snugly within the central opening (242) of the femoral component (236).

By providing the posterior stabilized design with the central post (230), as the knee is flexed, the horizontal bar cam (243) acts as a cam on the femoral component (236) to engage the post (230) at surface (233) on the tibial component (202), causing the femoral posterior condyles (238, 239) to roll back onto the tibial articular concavity surfaces (204, 205). This "roll back" coupled with "climbing" the posterior aspect of the tibial articular surface at (233), causes the femoral component (236) to be located out of the lowest aspect of the tibial articular surfaces (204, 205). With this condition, any type of varus/valgus loading of the joint will cause one of the femoral condyles to apply higher downward loads than the opposing condyle. With a differential in loads, the tibial component (202) will freely spin until the higher loaded condyle displaces to the low point of the tibial articular surface. The central tibial post (216) forces the opposite condyle out of the posterior aspect of the tibial articular surface, thus creating a spin out.

tThe present invention allows for a free, unlimited rotation of the tibial ;insert (202) relative to its baseplate All of the rotational constraints O occurs between the femoral component (236) and the insert (202). The present invention builds conformity of the central post (230) of the insert (202) relative to the box of the femur in rotation, but allowing for 00 varus/valgus tilting. The present invention produces a generally trapezoidal Sinsert post (230).

IND

A sixth alternate embodiment of the apparatus of the present invention is shown in Figs. 69 81. In the embodiment of Figs. 69 -81, a mobile bearing knee prosthesis (254) features a two-part polymeric insert that includes first member (255) shown in Figs. 69 -75 and a second member (264) shown in Figs. 69 and 76 81. Polymeric insert (255) (see Figs. 70 75) has a central opening (256) that is bordered by a pair of spaced apart, generally parallel shoulders (257, 258) upon which second member (264) slides fore and aft. The insert (255) has a periphery (259) a proximal surface with a pair of concavities (260, 261). The insert member (255) includes a flat distal surface (262).

The second insert member (264) has a proximal surface (265), a distal surface (267) and a passageway (263) that extends between the surfaces (265, 267). A pair of spaced apart, generally parallel shoulders (268, 269) are provided on opposing sides of insert 9264) as shown in Figs. 77, 79 and 81. Flat surfaces (270, 271) are also provided on opposing sides of insert member (264). The surface (270) is generally perpendicular to shoulder (268). The surface (277) is generally perpendicular to the shoulder (267) as shown in Fig. 79.

Insert member (264) provides a post (272). Post (272) has flat, proximal surface (273), anterior surface (274), posterior surface (275), and sides (276, 277). The member (264) provides a curved anterior surface O (278) that is correspondingly shaped to and fits against the correspondingly shaped concave surface (279) of member (255) at opening (256).

O During use, the shoulders (268, 269) of insert member (264) fit against and slide upon the shoulders (257, 258) of insert member (255). Flat _surfaces (270, 271) of insert member (264) engage and slide against flat 00

O

surfaces (280, 281) of insert (255). The insert member (264) slides upon Sthe insert member (255) in an anterior to posterior direction because the N opening (256) is longer than the insert member (264). The opening (256) is larger in an anterior to posterior direction than the length of the insert member (264) measured from an anterior to posterior direction such as between surfaces (278) and (280).

The present invention includes a posterior stabilizing post (272) secured to the central insert member (264). The posterior stabilized post (272) captures or is captured by bearing insert component (255) to the tibial baseplate (13) through an elongated slot or opening (256) in the bearing component (255). The elongated opening or slot (256) in the bearing component member (255) allows it to translate anteriorly and posteriorly with respect to the posterior stabilized post (272) of the insert member (264). The bearing component (255) may also rotate with respect to the tibial baseplate (13) in conjunction with the posterior stabilized post (272).

The bearing component (255) has two concave surfaces (260, 261) that are configured to articulate with the convex surfaces [condylar portions](240, 241) of the femoral component (236) at full extension. The posterior stabilized post (272) articulates with a horizontal bar cam (243) of the femoral component (236) to provide femoral roll back.

The bearing design of the present invention thus consists of a bearing articular insert (255) with a separate posterior stabilized post component (264) that may have one or more degrees of freedom. The bearing articular insert (251) has two concave surfaces (260, 261) that articulate with the convex surfaces [condylar portions](240, 241) of the femoral component (236) at full extension. The posterior stabilized post (272) articulates with a recess or cam (243) of the femoral component (236) to provide femoral roll back. The rotational freedom of the posterior stabilized post (272) maintains contact with the femoral bar cam (243) during external or internal 00 rotation of femoral component (236).

IThe posterior stabilized member (255) has a flat distal surface (262) that articulates with the tibial baseplate A tee slot (266) is located n the distal surface (267) and articulates with a tee post (18) on the tibial baseplate (13) (see Figs. 1 -17 for such a tee slot and tee post connection).

A through hole (263) in the component (264) is located such that a rotation peg (such as peg (24) in Figs. 1 7) can capture the component (264) to the tibial baseplate (13) while the tee slot of the insert component (264) is engaged with a tee post (18) of the tibial baseplate. Rotation peg (24) allows only rotational freedom of the insert component (264) with respect to the tibial baseplate The elongated slot (256) of the bearing component (255) is larger than the posterior stabilized post carrying component (255) in the anterior-posterior direction such that the bearing component has limited translation with respect to the posterior stabilized post. The bearing component (255) may also rotate with respect to the tibial baseplate (13) in conjunction with posterior stabilized post component (264).

Horizontal bar cam mechanism (243) on the femoral component (236) is preferably a concavely shaped cylinder as shown in Figs. 59 and 68, that registers against and engages the convex posterior surface (275) of the posterior stabilized post (272). The internal/external rotation of the posterior stabilized post component (264) with the femoral component (236) maintains this contact throughout the range of motion.

As an alternate construction, the second (central) insert member (264) could rotate only with respect to the tibial prosthesis, and the first (peripheral) insert member could both rotate and translate with respect to the tray.

PARTS LIST The following is a list of suitable parts and materials for the various elements of the preferred embodiment of the present invention.

Part Number 11 12 13 13A 14 16 17 18 19 21 22 23 24 26 27 28 29 31 32 33 34 36 37 Description mobile bearing knee prosthesis tibia surgically cut proximal surface tray tray flat proximal surface flat distal surface spike stem post internally threaded socket cylindrically-shaped section flange periphery recess fastener externally threaded section head tool receptive socket insert flat distal surface concavity concavity periphery vertical channel proximal, cylindrically-shaped section oval shaped slot distal opening oval section 0 38 half oval section 39 flat surface t: 40 flat surface 41 arrow/angle 42 post 43 cylindrical surface 44 circular top rectangular base 00 46 inclined side wall 47 tray socket 48 inclined surface IN 49 post vertical side wall 51 inclined surface 52 flat top 53 post 54 vertical side wall vertical end wall 56 flat top 57 rectangular base 58 inclined surface 59 post flat top 61 vertical side wall 62 rectangular base 63 inclined surface 64 insert opening arrow 66 arrow 110 mobile bearing knee prosthesis 111 tibia 112 surgically cut proximal surface 113 tray 114 flat proximal surface 114A opening 115 flat distal surface 116 spike 117 stem 118 post 119 socket 120 periphery of tray 121 insert 122 flat distal surface 123 proximal surface 124 concavity 125 concavity 126 slot 127 locking plug member 0 128 frustoconical outer surface 129 socket 130 threaded bore 131 locking screw 00 132 internally threaded opening on 133 annular shoulder 134 enlarged annular shoulder I0 135 periphery of insert 136 opening c 137 frustoconical portion 138 annular reference line 139 frustoconical surface 140 enlarged head 141 arrows 142 mobile bearing knee prosthesis 143 tray 144 proximal surface 145 distal surface 146 stem 147 frustoconical socket 148 plug 149 frustoconical surface 150 cylindrical surface 151 bevelled annular surface 152 flat end surface 153 flat end surface 154 plug 155 frustoconical surface 156 reduced diameter cylindrical surface 157 flat end surface 158 flat end surface 159 insert 160 proximal concavity 161 proximal concavity 162 flat distal surface 163 elongated slot 164 cylindrical opening 165 arrow 200 mobile bearing knee prosthesis 201 surgically cut femur 0 202 polymeric insert 203 flat distal surface 204 concavity 205 concavity 206 periphery C n 207 vertical channel 208 proximal cylindrically-shaped section 209 oval shaped slot 00 210 mobile bearing knee prosthesis M 213 tray S214 flat proximal surface D 215 flat distal surface 216 spike C 217 stem 218 post 219 internally threaded socket 220 cylindrically-shaped section 221 flange 222 periphery 223 recess 224 distal opening 225 flat surface 226 oval section 227 half oval section 228 flat surface 229 flat surface 230 central post 231 proximal surface 232 anterior surface 233 posterior surface 234 side 235 side 236 femoral component 237 anterior portion 238 posterior condylar portion 239 posterior condylar portion 240 distal condylar portion 241 distal condylar portion 242 central opening 243 horizontal bar cam 244 vertical wall 245 vertical wall 246 flat surface 247 flat surface INDr 248 flat surface 249 flat surface 250 flat surface 251 central longitudinal axis 0 252 arrow 253 arrow 254 mobile bearing knee prosthesis 255 polymeric insert bearing component 0 256 central opening 257 shoulder 258 shoulder

(N

D 259 periphery 260 concavity S261 concavity 262 distal surface 263 through hole 264 central insert component 265 proximal surface 266 tee slot 267 distal surface 268 shoulder 269 shoulder 270 flat surface 271 flat surface 272 post 273 flat proximal surface 274 anterior surface of post 275 posterior surface of post 276 side 277 side 278 curved anterior surface 279 concave surface 280 posterior surface 281 flat surface 282 flat surface The foregoing embodiments are presented by way of example only; the scope of the present invention is to be limited only by the following claims.

O Throughout this specification and the claims which follow, unless the context requires otherwise, the word "comprise", and variations such as "comprises" and "comprising", will be understood to imply the inclusion of a Ostated integer or step or group of integers or steps but not the exclusion of any other integer or step or group of integers or steps.

00 The reference in this specification to any prior publication (or Sinformation derived from it), or to any matter which is known, is not, and N should not be taken as an acknowledgment or admission or any form of suggestion that that prior publication (or information derived from it) or known matter forms part of the common general knowledge in the field of endeavour to which this specification relates.

Claims

1. A knee prosthesis apparatus comprising: a. a tibial component configured to be surgically implanted on a patient's transversely cut proximal tibia; b. a femoral component; 00 c. a fixator for holding the tibial component on the patient's 0proximal tibia; (N d. a tibial insert having a proximal surface that is shaped to engage the femoral component, the insert having a distal surface that fits against and articulates with the proximal surface of the tibial component. e. a constraining mechanism that joins the tibial insert to the tibial component in a selective fashion that enables a number of different possible relative motions between the insert and tibial component, including anterior to posterior translation with rotation, or rotation only; and f. wherein all or part of the constraining mechanism is separable from the tibial component, and selective removal of all or part of the constraining mechanism determines which of the said possible relative motions will take place.

2. A knee prosthesis of claim 1 wherein the tibial prosthesis has a fixator for holding the tibial component on the patient's proximal tibia.

3. A knee prosthesis of claim 1 wherein the proximal surface of the insert has one or more concavities for articulating with the femoral component.

4. A knee prosthesis of claim 1 wherein there are two concavities that define articulation surfaces on the proximal surface of the tibial insert. O 5. A knee prosthesis of claim 1 wherein the constraining mechanism includes a post extending up from the proximal surface of the tibial insert.

6. A knee prosthesis of claim 5 wherein the femoral component includes an intercondylar surface that is positioned to contact the post, o00 enabling relative motion between the femoral component and the insert to be constrained. IN 7. A knee prosthesis of claim 5 wherein the post has a socket and the 0 constraining mechanism includes a locking member that is connectable to the socket on the post.

8. A knee prosthesis of claim 1 wherein the constraining mechanism includes a post extending up from the proximal surface of the insert, a slot on the distal surface of the insert, an opening on the proximal surface of the insert that communicates with the slot and a locking plug member that can access and connect to the post from the proximal surface of the insert via the opening.

9. A knee prosthesis of claim 8 wherein the femoral component includes an intercondylar surface that is positioned to contact the post, enabling relative motion between the femoral component and the insert to be constrained. A knee prosthesis of claim 8 wherein the constraining mechanism includes a socket on the post that receives the locking member, wherein the locking plug member is attached to the post for further defining movement between the insert and tray.

11. A knee prosthesis of claim 10 wherein the locking member includes a plug. O 12. A knee prosthesis of claim 8 wherein the opening is defined by an annular surface that fits closely to the locking plug member when the locking plug member is connected to the pot.

13. A knee prosthesis of claim 1 wherein the constraining mechanism includes an opening that extends from the proximal to the distal 00 surface of the insert and a variety of connectable portions which are rselectively attachable to or separable from the tray, and wherein the N geometry of the various connectable portions relative to the opening 0 enables a user to determine which of the relative motions will take S 10 place.

14. A knee prosthesis of claim 1 wherein the tibial insert has a post. A knee prosthesis of claim 1 wherein a slot extends through the insert, communicating with both the proximal and distal surfaces of the insert, the slot enabling both anterior to posterior translation and rotation of the insert relative to the tibial component.

16. A knee prosthesis of claim 1 wherein the slot has an elongated section that communicates with the distal surface of the insert.

17. A knee prosthesis of claim 1 wherein the slot has a generally cylindrically-shaped section that communicates with the proximal surface of the insert.

18. A knee prosthesis of claim 15 wherein the slot has a larger transverse cross section at the distal surface of the insert and a smaller transverse cross section at the proximal surface of the insert.

19. A knee prosthesis of claim 1 or 18 wherein the tibial insert has a post.

20. A knee prosthesis of claim 1 wherein the constraining mechanism includes a post extending up from the proximal surface of the tibial insert. 6 21. A knee prosthesis of claim 20 wherein the femoral component includes an intercondylar surface that is positioned to contact the post, enabling relative motion between the femoral component and the Sinsert to be constrained.

22. A knee prosthesis apparatus comprising: 0 a. wherein the tibial component that includes a tibial tray portion adapted to be surgically implanted on a patient's transversely cut proximal tibia; b. wherein the femoral component that engages the tibial component; c. a post mounted on the proximal surface of the tray, the post having a socket; d. a tibial insert having an articulation surface for articulating with the femoral component, the insert having a distal surface that fits against and moves on the proximal surface of the tray; e. a generally vertical channel at the central portion of the insert that extends through the insert, the opening including an elongated slot portion that extends a partial distance through the insert, beginning at the distal surface of the insert and terminating at a position intermediate the proximal and distal surfaces of the insert, the slot extending generally along an anterior to posterior line; f. the slot removably connecting to and sliding with respect to the post of the tray; and g. a locking member for selectively locking the insert and tray together with a rotational connection, the member extending through the insert to connect with the post on the tray; h. the insert and tray being configured to enable selected relative motion between the insert and tray by respectively connecting or disconnecting the plug, wherein the insert is rotatable relative to the tray when the plug connects to the post; and i. wherein the insert is slidable and rotatable relative to the tray 0when the plug is disassembled from the post.

23. A knee prosthesis of claim 19 wherein the constraining mechanism 0 includes a post extending up from the proximal surface of the tibial insert. IND

24. A knee prosthesis of claim 23 wherein the femoral component Sincludes an intercondylar surface that is positioned to contact the post, enabling relative motion between the femoral component and the insert to be constrained. A knee prosthesis of claim 22 wherein the post has a socket that receives the locking plug member.

26. A knee prosthesis of claim 22 wherein the slot extends through the insert, communicating with both the proximal and distal surfaces of the insert.

27. A knee prosthesis of claim 22 wherein the slot has a larger transverse cross section at the distal surface of the insert and a smaller transverse cross section at the proximal surface of the insert.

28. A knee prosthesis of claim 22 wherein the channel extends completely through the insert and the locking member extends through the insert from the proximal surface of the insert to connect with the post.

29. A knee prosthesis of claim 27 wherein the channel closely conforms to the locking member at the proximal surface of the insert.

30. A knee prosthesis apparatus as claimed in claim 1 wherein the tibial component has a tibial tray portion configured to be surgically implanted on a patient's transversely cut proximal tibia such that the O fixator holds the tray on the patient's proximal tibia and wherein the proximal surface of the tibial insert, includes medial and lateral ;concavities and a projecting member positioned in between said 0 concavities, the insert having a distal surface that fits against and articulates with the proximal surface of the tray 00 31. A knee prosthesis of claim 30 wherein the proximal surface of the r-- insert has one or more concavities for articulating with the femoral N component.

32. A knee prosthesis of claim 30 wherein there are two concavities that define the articulation surface.

33. A knee prosthesis of claim 30 wherein the constraining mechanism includes a post extending superiorly from the proximal surface of the tibial insert.

34. A knee prosthesis of claim 30 wherein the post has a socket and the constraining mechanism includes a locking member that is connectable to the socket on the post. A knee prosthesis of claim 34 wherein the locking member includes a plug.

36. A knee prosthesis of claim 30 wherein the femoral component includes an intercondylar surface that is positioned to contact the post, enabling relative motion between the femoral component and the insert to be constrained.

37. A knee prosthesis of claim 30 wherein the constraining mechanism includes a post extending up from the proximal surface of the tibial tray, a slot on the distal surface of the insert, an opening on the proximal surface of the insert that communicates with the slot and a locking plug member that can access and connect to the post from the proximal surface of the insert via the opening. O 38. A knee prosthesis of claim 30 wherein the constraining mechanism includes a socket on the post that receives the locking plug member, wherein the locking plug member is attached to the post for further defining movement between the insert and tray.

39. A knee prosthesis of claim 30 wherein the opening is defined by an 00oo annular surface that fits closely to the locking plug member when the locking plug member is connected to the post. I 40. A knee prosthesis of claim 30 wherein the constraining mechanism 0 includes an opening that extends from the proximal to the distal surface of the insert and a variety of connectable portions which are selectively attachable to or separable from the tray, and wherein the geometry of the various connectable portions relative to the opening enables a user to determine which of the relative motions will take place.

41. A knee prosthesis of claim 30 wherein the tibial insert has a posterior projecting portion.

42. A knee prosthesis apparatus as claimed in claim 1 in which the tibial component includes a tibial tray portion adapted to be surgically implanted on a patient's transversely cut proximal tibia; and the femoral component engages the tibial component; further comprising a post mounted at the central portion of the proximal surface of the tray, the post having a socket; further wherein the tibial insert having a proximal surface that engages the femoral component, the proximal surface including medial and lateral concavities and a projecting member positioned in between said concavities, the insert having a distal surface that fits against and articulates with the proximal surface of the tray; also comprising a generally vertical channel at the central portion of the insert that extends through the insert, the opening including an elongated slot portion that extends a partial distance through the insert, beginning at the distal surface of the insert and O terminating at a position intermediate the proximal and distal surfaces of the insert, the slot extending generally along an anterior to posterior ;line; the slot removable connecting to and sliding with respect to the Opost of the tray; and a locking member for selectively locking the insert and tray together with rotational connection, the plug member extending through the insert to connect with the post on the tray; the 00 insert and tray being configured to enable selected relative motion 0 between the insert and tray by respectively connecting or IND disconnecting the plug, wherein the insert is rotatable relative to the tray when the plug connects to the post; and wherein the insert is slidable and rotatable relative to the tray when the plug is disassembled from the post.

43. A knee prosthesis of claim 42 wherein the femoral component includes an intercondylar surface that is positioned to contact the post, enabling relative motion between the femoral component and the insert to be constrained.

44. A knee prosthesis of claim 42 wherein the tibial insert has a post. A knee prosthesis of claim 42 wherein the post has a socket that receives the locking plug member.

46. A knee prosthesis of claim 42 wherein the slot extends through the insert, communicating with both the proximal and distal surfaces of the insert.

47. A knee prosthesis of claim 42 wherein the slot has a larger transverse cross section at the distal surface of the insert and a smaller transverse cross section at the proximal surface of the insert.

48. A knee prosthesis of claim 42 wherein the channel extends completely through the insert and the locking member extends through the insert at the proximal surface of the insert to connect with the post. O 49. A knee prosthesis of claim 42 wherein the channel closely conforms to the locking member at the proximal surface of the insert. A knee prosthesis apparatus comprising: a. a tibial component including a tibial tray portion configured to be surgically implanted on a patient's transversely cut proximal tibia; 00 Sb. a fixator for holding the tibial component on the patient's Oproximal tibia; IND c. a tibia insert having first and second removably connectable i members, including a peripheral member having a central opening and a central member that connects to the central opening the insert having a distal surface that fits against and articulates with the proximal surface of the tibial component; d. a femoral component; e. a constraining mechanism that joins the insert to the tibial tray portion during use in a selective fashion that enables a number of different possible relative motions between the insert and tibial tray including anterior to posterior translation and rotation or rotation only; and f. wherein all or part of the constraining mechanism is separate from the tray and selective removal of all or part of the constraining mechanism determines which of the said possible relative motions will take place.

51. A knee prosthesis of claim 50 wherein the constraining mechanism includes a post extending up from the proximal surface of the tibial insert.

52. A knee prosthesis of claim 51 wherein the femoral component includes an intercondylar surface that is positioned to contact the post, O enabling relative motion between the femoral component and the (N tinsert to be constrained.

53. A knee prosthesis of claim 50 wherein the central member slidably connects to the peripheral member.

54. A knee prosthesis of claim 50 wherein the central member connects to 00 the tray and the peripheral member connects to the central member. A knee prosthesis of claim 50 wherein the proximal surface of the insert has one or more concavities for articulating with femoral component.

56. A knee prosthesis of claim 50 wherein there are two concavities that define the articulation surface.

57. A knee prosthesis of claim 50 wherein the constraining mechanism includes a post extending up from the proximal surface of the tibial tray.

58. A knee prosthesis of claim 57 wherein the central member connects to the post.

59. A knee prosthesis of claim 50 wherein the post has a socket and the constraining mechanism includes a locking plug member that is connectable to the socket on the post.

60. A knee prosthesis of claim 50 wherein the constraining mechanism includes a post extending up from the proximal surface of the tibial tray, a slot on the distal surface of the insert, an opening on the proximal surface of the insert that communicates with the slot and a locking plug member that can access and connect to the post from the proximal surface of the insert via the opening.

61. A knee prosthesis of claim 60 wherein the femoral component includes an intercondylar surface that is positioned to contact the post, O enabling relative motion between the femoral component and the insert to be constrained.

62. A knee prosthesis of claim 50 wherein the constraining mechanism includes a socket on the post that receives the locking plug member, wherein the locking plug member is attached to the post for further OO defining movement between the insert and tray.

63. A knee prosthesis of claim 50 wherein the opening is defined by an I annular surface that fits closely to the locking plug member when the Olocking plug member is connected to the post.

64. A knee prosthesis of claim 50 wherein the constraining mechanism includes an opening that extends from the proximal to the distal surface of the insert and a variety of connectable portions which are selectively attachable to or separable from the tray, and wherein the geometry of the various connectable portions relative to the opening enables a user to determine which of the relative motions will take place. A knee prosthesis apparatus as claimed in claim 50 further comprising: a. a post mounted at the central portion of the proximal surface of the tray, the post having a socket; b. a generally vertical channel at the central portion of the insert that extends through the insert, the opening including an elongated slot portion that extends a partial distance through the insert, beginning at the distal surface of the insert and terminating at a position intermediate the proximal and distal surfaces of the insert, the slot extending generally along an anterior to posterior line; c. the slot removably connecting to and sliding with respect to the post of the tray; and O d. a locking member for selectively locking the insert and tray together with a rotational connection, the locking member ;extending through the insert to connect with the post on the tray; wherein e. the insert and tray being configured to enable selected relative motion between the insert and tray by respectively connecting or OO disconnecting the locking member wherein the insert is rotatable relative to the tray when the locking member connects to the IN post; and N 10 f. wherein the insert includes first and second connectable members being rotatable relative to the tray when the locking member is assembled the post.

66. A knee prosthesis of claim 65 wherein the constraining mechanism includes a post extending up from the proximal surface of the tibial insert.

67. A knee prosthesis of claim 66 wherein the femoral component includes an intercondylar surface that is positioned to contact the post, enabling relative motion between the femoral component and the insert to be constrained.

68. A knee prosthesis of claim 65 wherein the tibial insert has a post.

69. A knee prosthesis of claim 65 wherein the post has a socket that receives the locking plug member. A knee prosthesis of claim 65 wherein the slot extends through the insert, communicating with both the proximal and distal surfaces of the insert.

71. A knee prosthesis of claim 69 wherein the slot has a larger transverse cross section at the distal surface of the insert and a smaller transverse cross section at the proximal surface of the insert. 0 72. A knee prosthesis of claim 69 wherein the channel extends completely through the insert and the locking member extends through the insert ;at the proximal surface of the insert to connect with the post.

73. A knee prosthesis of claim 67 wherein the channel closely conforms to the locking plug at the proximal surface of the insert. 00

74. A knee prosthesis of claim 67 wherein the first and second Oconnectable members are slidably connected during use. (NO A knee prosthesis of claim 50 in which the femoral component articulates with the insert.

76. A knee prosthesis of claim 65 in which the femoral component engages the tibial component. Dated this 30th day of August, 2006 Smith Nephew, Inc. by their Patent Attorneys DAVIES COLLISON CAVE