Tibial Tray Inserter

Abstract

To provide implants, instruments, systems and methods of installing tibial tray implants.SOLUTION: Tibial implants, instruments, systems and methods of implanting a tibial tray during knee arthroplasty. The inserter instrument may include a main body with a pair of fixed posterior tabs, a moveable anterior tab body with an anterior tab, and a rotatable shaft for controlling movement of the anterior tab body. When the shaft is rotated, the anterior tab body is translated into an expanded position to lock the inserter to the tibial tray, thereby providing precise positioning of the tibial tray during the implantation.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present disclosure relates generally to knee arthroplasty, and more particularly to knee arthroplasty instruments, implants, and methods of installing knee arthroplasty implants. [Background technology]

[0002] Knee arthroplasty, often referred to as knee replacement, is a surgical procedure used to reconstruct and resurface a knee damaged by, for example, arthritis. A total knee arthroplasty (TKA) device can replace both the tibiofemoral joint and the patellofemoral joint. The tibiofemoral joint is where the tibia and femur articulate. The patellofemoral joint is where the patella and femur articulate. To replace the tibiofemoral joint, knee arthroplasty may include a femoral trial (or implant) secured to the distal end of the femur, a tibial tray (or implant) secured to the proximal end of the tibia, and an insert disposed therebetween. The femoral and tibial implants cover the ends of the femur and tibia, respectively, which form the knee joint, thereby reconstructing the knee. To replace the patellofemoral joint, knee arthroplasty may include a patellar prosthesis (or implant) to take the place of the underside of the patella and create a replacement articulating surface that interacts with a femoral trial or implant.

[0003] The tibial portion of the procedure may include a planar resection of the proximal tibia which is replaced with a tibial implant assembly including a tibial tray and an articulating spacer insert. The tibial tray may include a keel structure to provide additional support to and fixation to the cancellous bone of the tibia. A keel drill may be utilized to create an initial cavity to allow the keel of the tibial tray to seat on the resected tibia. The placement of the tibial tray is predetermined in part by the keel drill cavity, but may be slightly altered by the surgeon when implanting the tibial tray. There is a need for an improved tibial tray and an inserter instrument configured for implanting the tray that allows for six degrees of freedom of movement and precise placement control of the tibial tray during implantation. Summary of the Invention

[0004] To meet this and other needs, implants, instruments, systems, and methods for installing a tibial tray implant are provided. In particular, the inserter instrument can be configured to lock to the tibial tray with one or more locking mechanisms. For example, the tibial tray can include one or more pockets configured to receive corresponding tabs of the inserter. An anterior tab of one of the inserter can be slidable to engage and disengage one of the pockets of the tibial tray. The tibial tray can be attached to the inserter to provide improved control of six degrees of freedom of movement. In this manner, the surgeon can adjust the placement of the tibial tray based on the surgeon's preferences and desired patient outcomes. The inserter may also be used to extract the tibial tray during a revision procedure. The implant can further include an insert that can be attached to the tibial tray via the same pocket used for the inserter.

[0005] According to one embodiment, a system for knee arthroplasty includes a tibial tray and an inserter. The tibial tray has a peripheral wall defining an insert receiving space, the peripheral wall defining a pair of posterior notches / undercuts and a single anterior notch / undercut. The inserter has a body having a pair of fixed posterior tabs, a movable anterior tab body having an anterior tab, and a rotatable shaft for controlling movement of the anterior tab body. The posterior tabs are receivable within the posterior notches of the tibial tray and the anterior tab is receivable within the anterior notch of the tibial tray when the shaft is rotated and the anterior tab body translates to an extended position.

[0006] The system may include one or more of the following features: The tibial tray may have a kidney shape with an anterior side forming a lateral convex side and a posterior side including a medial concave side separating two lobes. The tibial tray may include a keel attached to a distal surface of the tibial tray, the keel may include a pair of coronal fins and a pair of sagittal fins. In a cementless procedure, the tibial tray may also include a plurality of pegs attached to the distal surface of the tibial tray. The body of the inserter may include a foot having an upwardly projecting neck and an anteriorly projecting arm. The foot may be bifurcated by a keyway such that the anterior tab body is receivable within the keyway. The anterior tab body may include a pair of keyway wings projecting outwardly in opposite directions. The keyways may define recesses configured to receive the respective keyway wings, thereby preventing anterior-posterior angulation while expansion is occurring. The inserter may include a plurality of plugs press-fit into the body and the anterior tab body. The plug may be secured with a transverse dowel pin that extends through the plug body and may protrude from the bottom of the body, thereby ensuring that the body does not contact or damage the insert-receiving space of the tibial tray.

[0007] According to one embodiment, an inserter instrument for implanting a tibial tray includes a body, a movable anterior tab body, and a rotatable shaft. The body is coupled to a handle. The body includes a pair of rear tabs. The movable anterior tab body is located within the body. The anterior tab body includes a threaded opening and an anterior tab. A rotatable shaft controls movement of the anterior tab body. The shaft has a threaded portion that engages with the threaded opening of the anterior tab body. The shaft is positioned through the body and the anterior tab body. As the shaft rotates, the anterior tab body translates outwardly of the body to a locked position.

[0008] The inserter instrument may include one or more of the following features: The body may include a foot having an upwardly projecting neck and a forwardly projecting arm. The foot may have a kidney bean profile. The foot may be bifurcated by a keyway, and the front tab body may be receivable within the keyway. The front tab body may include a pair of keyway wings projecting outwardly in opposite directions. The keyway may define a recess configured to receive a respective keyway wing, thereby preventing anterior-posterior angulation while expansion is occurring. The front tab body may include a base having an upwardly projecting tongue that defines a threaded opening. The threaded opening may be a three start lead screw hole, and the shaft may include a three start lead shaft configured to interact with the three start lead screw hole to increase the translational speed of the front tab body. The front tab may be positioned along a front portion of the base, and the front tab may extend along the entire width of the front tab body. The handle may include an elongate body terminating distally in a threaded end that may mate with corresponding threads on the body.

[0009] According to another embodiment, a method for implanting a tibial implant includes one or more of the following steps in any suitable order: (1) positioning a fixed posterior tab of the body of the inserter into a corresponding posterior notch in the peripheral wall of the tibial tray, (2) tilting the tibial tray until the foot of the inserter body is received within the insert receiving space of the tibial tray, (3) rotating a shaft through the body of the inserter to translate the anterior tab body and expand the anterior tab into the anterior notch of the tibial tray, thereby locking the inserter to the tibial tray, and (4) moving the tibial tray to a desired position and embedding the tibial tray into the patient's proximal tibia. The inserter may be configured to move the tibial tray with internal / external rotation, proximal / distal translation, anterior / posterior translation, anterior / posterior angulation, medial / lateral translation, and varus / valgus angulation. The method may include resecting the proximal tibia to form a planar resection surface and / or drilling a cavity in the proximal tibia prior to positioning the inserter, the cavity may be configured to receive the keel of the tibial tray. After removing the inserter, the insert may be attached by tabs receivable in the same posterior and anterior notches of the tibial tray.

[0010] Also provided are kits that include various types and sizes of implants or implant trials, including tibial trays and inserts, in different anterior-posterior (AP) and / or medial-lateral (ML) orientations, and various types and configurations of instruments, including lockable inserter instruments, and other components for performing the procedure. [Brief description of the drawings]

[0011] A more complete understanding of the present invention, together with its attendant advantages and features, will be more readily appreciated by reference to the following detailed description when considered in conjunction with the accompanying drawings, in which: [Figure 1] 1 illustrates a perspective view of an inserter instrument locked to a tibial tray for implanting the tibial tray into a resected portion of a patient's proximal tibia, according to one embodiment. [Diagram 2] 1 illustrates an assembled anterior perspective view of an insert and tibial tray according to one embodiment. [Diagram 3] FIG. 1 is a front view of an insert and tibial tray assembly according to one embodiment. [Figure 4] FIG. 2 shows an exploded perspective view of the insert and tibial tray from the anterior view. [Diagram 5] FIG. 2 shows an exploded perspective view of the insert and tibial tray from a posterior perspective. [Figure 6] 13A-13C show cross-sectional and close-up views of an insert coupled with a tibial tray including a posterior tab locking mechanism, according to one embodiment. [Figure 7] 13A-13C show cross-sectional and close-up views of an insert coupled with a tibial tray including a posterior tab locking mechanism, according to one embodiment. [Figure 8] 13A-13C show cross-sectional and close-up views of an insert coupled with a tibial tray including an anterior tab locking mechanism, according to one embodiment. [Figure 9] 13A-13C show cross-sectional and close-up views of an insert coupled with a tibial tray including an anterior tab locking mechanism, according to one embodiment. [Figure 10] 1 illustrates an exploded view of an inserter tool, according to one embodiment. [Figure 11] FIG. 1 illustrates a perspective view of a body of an inserter instrument, according to one embodiment. [Figure 12] FIG. 13 is a close-up view of the fixed rear tab of the body of the inserter instrument, according to one embodiment. [Figure 13] FIG. 13 shows a rear view of a body of an inserter instrument having a keyway for receiving a movable front tab body, according to one embodiment. [Figure 14] 1 illustrates a perspective view of a front tab body according to one embodiment. [Figure 15] 1 illustrates a perspective view of a shaft configured to translate a front tab body according to one embodiment. [Figure 16] 14 illustrates a perspective view of one of the plastic plugs configured to prevent metal-to-metal contact between the inserter and the tibial tray, according to one embodiment. [Figure 17]11 shows a perspective view of the inserter instrument of FIG. 10 in an unlocked or retracted position. [Figure 18] 11 shows a perspective view of the inserter device of FIG. 10 in a locked or extended position. [Figure 19] 13 illustrates attachment of an insert to a tibial tray according to one embodiment. [Figure 20] 13 shows a cross-sectional view of the inserter with the front tabs expanding, thereby locking the inserter to the tibial tray. [Figure 21] FIG. 13 is an enlarged cross-sectional view of a front tab of the inserter engaged with the tibial tray. [Figure 22] FIG. 13 is a cross-sectional view of the inserter with the front tab retracted, thereby unlocking and removing the tibial tray from the inserter. [Diagram 23] 1A-1D show oblique, lateral, and anterior views, respectively, of a tibial tray implanted into the proximal tibia, including control for six degrees of freedom of movement via the inserter. [Figure 24] 1A-1D show oblique, lateral, and anterior views, respectively, of a tibial tray implanted into the proximal tibia, including control for six degrees of freedom of movement via the inserter. [Diagram 25] 1A-1D show oblique, lateral, and anterior views, respectively, of a tibial tray implanted into the proximal tibia, including control for six degrees of freedom of movement via the inserter. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012] Embodiments of the present disclosure are generally directed to implants, instruments, systems, and methods for implanting a tibial tray, for example, during a total knee arthroplasty. Specifically, embodiments are directed to instruments and systems configured to lock an inserter instrument to the tibial tray to provide improved control and maneuverability of the tibial tray during implantation. The inserter instrument may utilize the same locking features as the insert, such as one or more pockets or notches in the tibial tray that receive one or more corresponding tabs. The inserter instrument may include a movable anterior tab to provide a stationary locking mechanism for the tibial tray.

[0013] Additional aspects, advantages, and / or other features of the exemplary embodiments of the present invention will become apparent in view of the following detailed description. It will be apparent to those skilled in the art that the described embodiments provided herein are merely exemplary and illustrative, and not limiting. Numerous embodiments and modifications thereof are contemplated as falling within the scope of the present disclosure and equivalents thereto.

[0014] 1, an inserter instrument 10 is attached to a tibial tray 14 according to one embodiment for implanting the tibial tray 14 into the proximal end of a patient's tibia 2. During a total knee arthroplasty (TKA), a planar resection 4 is performed on the proximal tibia 2 and may be replaced with a prosthesis or tibial tray implant 14. The tibial tray 14 may be provided in a number of different sizes in anterior-posterior (AP) and medial-lateral (ML) orientations to accommodate the patient's anatomy. The tray 14 may include a keel structure 34 on a distal surface 24 of the tray 14 and one or more optional pegs 42 that provide additional support / fixation to the cancellous bone of the tibia 2 (e.g., in a cementless situation). A keel reefer (not shown) may be utilized to create an initial cavity 6 in the cancellous bone of the tibia 2 to allow the keel 34 of the tibial tray 14 to seat into the proximal tibia 2. One or more additional openings 8 may be formed in the resection 4 to allow for receipt of the pegs 42. After all necessary preparation of the tibia 2 has been made, the tibial tray 14 is implanted into the resected 4 and drilled 6 proximal tibia 2. The tibial tray 14 may be snapped into place to ensure proper seating of the tray 14. After the tray 14 is in place and the insert 10 is removed therefrom, the insert 16 may be connected to the tray 14 to complete the tibial implant assembly 12.

[0015] The placement of the tibial tray 14 is predetermined by the keel drilling cavity 6 created during tibial preparation, but may be slightly altered based on surgeon preference when implanting the tray 14. These alterations may be based on the surgeon's feel and preference during the process of implanting the tray 14, or other parameters. To allow the surgeon to make precise adjustments, the tibial tray 14 is mounted and locked into the inserter 10, which provides control of movement up to six degrees of freedom. Additionally, during revision procedures, the inserter 10 may be used to extract and remove the tibial tray 14, for example, by using a slap hammer threadably received in the inserter handle.

[0016] Although generally described with reference to knee arthroplasty, it should be understood that the instruments, implants, and systems described herein may be applied to other orthopedic locations and applications, such as the spine, including between vertebrae, long bones such as the femur, tibia, humerus, clavicle, fibula, ulna, radius, bones of the foot, bones of the hand, or other suitable bones or joints.

[0017] 2-9, the tibial implant assembly 12 is described in further detail. FIGS. 2 and 3 show the tibial implant assembly 12 including a tibial tray 14 sized and shaped for placement on the proximal end of a patient's tibia 2 and a liner or insert 16 receivable within the tray 14. The insert 16 includes an articulating or joint surface 52 configured to interface with a femoral implant (not shown). The insert 16 is positioned between the tibial tray 14 and the femoral implant to mimic the motion of a natural knee and provide support as the knee flexes and extends. Essentially, the insert 16 balances the joint space and provides an articulating surface as the knee moves through a physiological range of motion.

[0018] The implant assembly 12 may be constructed from one or more biocompatible materials. For example, the tibial tray 14 may be made from a metal such as titanium, stainless steel, cobalt chrome, carbon composite, or a suitable alloy. The insert 16 may be made from a plastic or polymer such as polyethylene, ultra-high molecular weight polyethylene (UHMWPE), polyetheretherketone (PEEK), or a combination of such materials. The femoral implant may also be made from a metal / metal alloy such as cobalt chrome or titanium. In this way, the components are configured such that the metal articulates against the plastic to provide smooth movement and minimize wear. These materials may be machined, cast, and constructed from additive manufacturing such as 3D printing, subtractive manufacturing, or hybrid manufacturing processes. While the materials described herein are illustrated, it will be understood that any suitable materials and constructions may be selected for the individual components.

[0019] 4 and 5, the tibial tray 14 includes a plate 20 including opposing proximal and distal surfaces 22, 24. The distal surface 24 of the tibial plate 14 is configured to engage the resected surface 4 of the tibia 2. The tibial plate 20 has a perimeter, wall, or lip 26 that defines an insert-receiving space 28 sized and shaped to receive the insert 16. The proximal surface 22 of the plate 20 defines a distal or bottom surface of the insert-receiving space 28.

[0020] The tibial plate 14 includes an anterior side 30 and an opposing posterior side 32. The outer contour of the tibial tray 12 may be rounded or curved. For example, the tibial tray 12 may have the general shape of a long oval with one side concave, such as a kidney bean shape. The anterior side 30 may form an outer convex side as one long side, and the posterior side 32 may include an inner concave side separating two lobes or two rounded ends. It will be appreciated that the tibial plate 20 and lip 26 may generally have any suitable size and shape configured to fit the particular size and shape of the proximal end of the patient's tibia 2.

[0021] The tibial implant 12 includes a tibial stem or keel 34. The tibial keel 34 is configured to be inserted into the drilled cavity 6 of the resection surface 4 at the proximal end of the patient's tibia 2. The tibial keel 34 is attached to the distal surface 24 of the tibial plate 20. The tibial keel 34 extends generally distally from the distal surface 24 of the tibial plate 20. The tibial keel 34 may be solid or hollow (e.g., may have a solid or hollow core).

[0022] The tibial keel 34 may include one or more fins 36, 38, including a coronal fin 36 and / or a sagittal fin 38. The coronal fins 36 (e.g., two fins 36) may extend from the center of the tibial keel 34 outward in a direction generally parallel to the patient's coronal plane (e.g., a plane extending in a vertical side-to-side direction). The coronal fins 36 may be at a slight angle, e.g., about 15 degrees or less, to the coronal plane to form a slight V-shape. The sagittal fins 38 (e.g., two sagittal fins) may extend from the center of the tibial keel 34 outward in a direction generally parallel to the patient's sagittal plane (e.g., a plane extending in a vertical anterior-posterior direction). The coronal fins 36 and sagittal fins 38 may taper or narrow inward as the fins 36, 38 extend distally. The width of the sagittal fin 38 may also taper medially (e.g., in a direction generally parallel to the coronal plane) as the fin 38 extends distally. The fins 36, 38 may have rounded edges to improve insertion into the cavity 6. The distal-most nose or tip 40 of the tibial keel 34 may be tapered or curved, for example, along the coronal and / or sagittal planes. It will be appreciated that other configurations or modifications to the tibial keel 34 may be provided to improve insertion and retention within the cavity 6 of the proximal tibia 6.

[0023] The tibial tray 14 may further include at least one anchoring projection or peg 42. Each peg 42 is configured to be inserted into a corresponding opening 8 in the resection 4 of the patient's proximal tibia 2. The pegs 42 may be provided on the tray 14 to provide additional support and / or additional fixation to the cancellous bone of the tibia 2, for example, in a cementless procedure. It will be appreciated that the tibial tray 14 may be implanted with or without cement. The pegs 42 extend generally distally from the distal surface 24 of the tibial plate 14. The pegs 42 may have a generally circular or conical shape (e.g., bullet shaped), or other suitable shapes may be used. The pegs 42 may include one or more peripheral ribs, for example, having rounded, chamfered, sharp, or filleted edges. The ribs may be configured to minimize bone displacement, risk of fracture, and / or increase surface area for bone ingrowth. The pegs 42 may be solid or hollow (e.g., may have a solid or hollow core). The pegs 42 may be spaced apart from one another around the periphery of the distal surface 24 of the tibial plate 20. For example, the pegs 42 may be disposed around the tibial keel 34 with the tibial keel 34 centered between the pegs 42. Any suitable quantity and arrangement of pegs 42 may be provided to achieve the desired support and fixation to the tibial tray 14. The pegs 42 may be substantially identical to one another or may be otherwise configured.

[0024] The tibial implant assembly 12 may form part of a fixed-bearing knee replacement in which the insert 16 is secured to the tibial tray 14. For example, the insert 16 may be snap-fit ​​into the insert space 28 using one or more locking members. As shown, the insert 16 may be locked to the tray 14 by one or more interlocking tabs 48, 50 and notches 44, 46. The peripheral wall 26 of the tray 14 may define one or more recesses, pockets, or notches 44, 46 that are used to receive a portion of the insert 16 and retain the insert 16 in the insert-receiving space 28 of the tibial tray 14.

[0025] The insert 16 includes a body having an upper articular surface 52 and an opposing lower surface 54 configured to be received within the insert receiving space 28 of the tibial tray 14. The upper articular surface 52 may be concave and contoured to articulate with a femoral component or implant (not shown). The lower surface 54 is configured to contact the proximal surface 22 of the tibial plate 20. An outer wall 56 of the insert 16 may have a general shape of a long oval concave on one side, such as a kidney bean shape, that generally corresponds to the outer shape of the tibial tray 14. A distal portion of the insert 16 defines a recessed collar 58 receivable within the insert receiving space 28 of the tibial tray 14. The collar 58 defines one or more tabs 48, 50 configured to engage corresponding pockets or notches 44, 46 of the tibial tray 14. The tabs 48, 50 may be defined by one or more slits or relief cuts to form resilient tabs.

[0026] The insert 16 may include a pair of rear tabs 48 positioned along a rear portion of the insert 16 and a single front tab 50 positioned along a front portion of the insert 16. As best seen in FIG. 5, the rear tabs 48 may be located on two lobes separated by an internal recess. The rear tabs 48 may each extend a length that extends in a direction generally parallel to the patient's coronal plane (e.g., a vertical side-to-side extending plane). The rear tabs 48 are receivable within a corresponding rear pocket or notch 44 of the tray 14. As best seen in FIG. 4, the front tab 50 may be located in the center of the convex side of the insert 16. The front tab 50 may also extend a length that extends in a direction generally parallel to the patient's coronal plane. The front tab 50 may be generally longer than each of the rear tabs 48. The front tab 50 is receivable within a corresponding front pocket or notch 46 of the tray 14.

[0027] The tibial tray 14 utilizes three pockets 44, 46 to allow tabs 48, 50 of the polyethylene (poly) insert 16 to lock into the tray 14. The posterior tab 48 fastens to the posterior pocket 44 of the tibial tray 14. The two pockets 44 located at the posterior of the tibial tray 14 may shift slightly in the medial-lateral orientation as the tray 14 increases in size. The single pocket 46 located at the anterior of the tray 14 may shift more in the anterior-posterior orientation. These tabs 48, 50 may be the only method for fastening the poly insert 16 or any instrument that may work in conjunction with the tray 14.

[0028] 6 and 7, the interlocking of the posterior tab 48 and the posterior notch 44 is shown in greater detail. The collar 58 may define a recess 60 proximal to the tab 48. The recess 60 may be configured to receive an inwardly facing lip 62 extending from the edge 26 of the tray 14. An upper surface of the lip 62 may be generally planar or flat. In this manner, when the collar 58 is received in the insert receiving space 28 of the tray 14, the posterior tab 48 is received in the notch 44 and the lip 62 is received in the recess 60, thereby securing the posterior portion of the insert 16 to the tibial tray 14.

[0029] Further highlighting FIGS. 8 and 9 , the connection between the anterior tab 50 and the anterior notch 46 is shown in more detail. The collar 58 may define a recess 64 proximally above the tab 50. The recess 64 may be configured to receive an inwardly directed lip 66 extending from the edge 26 of the tray 14. The lip 66 may define a bevel or chamfer on an upper surface along a leading edge of the lip 66 to aid in insertion into the recess 64. A relief cut 68 may be provided behind the anterior tab 50 to allow for additional flexibility and resiliency of the anterior tab 50. In this manner, when the collar 58 is received in the insert receiving space 28 in the tibial tray 14, the anterior tab 50 is received in the notch 46 and the lip 66 is received in the recess 64, thereby locking the anterior aspect of the insert 16 to the tibial tray 14.

[0030] 10-25, the inserter instrument 10 can utilize the same interlocking tab and existing notch 44, 46 configuration as the inserter 16 to lock the inserter 10 to the tibial tray 14. The lockable feature of the inserter instrument 10 to the tibial tray 14 allows for control over six degrees of freedom of movement and precise positioning of the tibial tray 14 during implantation. The six degrees of freedom can include internal / external rotation, proximal / distal translation, anterior / posterior translation, anterior / posterior angulation, medial / lateral translation, and varus / valgus angulation.

[0031] With emphasis on FIG. 10 , the inserter instrument 10 includes a body 102 coupled to a handle 104 and a front tab body 106 movable within the body 102. The front tab body 106 is controllable by a rotatable shaft 108, which causes the front tab body 106 to extend from the body 102, thereby locking the inserter 10 to the tibial tray 14. The inserter instrument 10 extends along a central longitudinal axis A from a proximal end 110 to a distal end 112. The proximal end 110 includes a handle 104 that is grippable and controllable by a user. The distal end 112 includes the body 102 configured to engage the tibial tray 14, thereby controlling the movement of the tibial tray 14 during impaction and insertion.

[0032] The handle 104 may be generally aligned along a central longitudinal axis A of the instrument 10. The handle 104 may include an elongated body 114 terminating distally in a threaded end 116. In the embodiment shown, the elongated body 114 may be generally cylindrical in shape and may have a hollow or central channel therethrough. The threaded end 116 may include one or more threads configured to mate with corresponding threads 128 on the body 102. The corresponding threads 128 may also be suitable for direct attachment to a slap hammer, as opposed to a typical instrument handle, if desired. The threaded end 116 of the handle 114 may have a reduced diameter relative to the outer diameter of the elongated body 114. The proximal end 110 of the handle 104 may include an enlarged head 118 having an outer diameter larger than the outer diameter of the elongated body 114. The enlarged head 118 may be configured to be struck by an impaction instrument, such as a mallet. It should be appreciated that the handle 104 may include a typical instrument handle or may be otherwise configured for manipulation by a user. The handle 104 may also include a threaded feature at the end 110 to allow for attachment of a slap hammer.

[0033] With emphasis on Figures 11-13, the body 102 includes a base or foot 120 having an upwardly or proximally projecting neck 122 and a forwardly projecting arm 124. The neck 122 defines a central opening 126 having one or more internal threads 128. The neck 122 and the central opening 126 may be generally aligned along a central longitudinal axis A of the instrument 10. When the threaded end 116 of the handle 114 is threaded into the opening 126, the handle 114 is secured to the body 102. It will be appreciated that other attachment methods may be used to secure the handle 114 to the body 102, including press fit, adhesives, pins, and the like.

[0034] The base or foot 120 is generally sized and shaped to fit within the insert receiving space 28 of the tibial tray 14. In other words, the outer wall of the foot 120 may have the same kidney shape that generally corresponds to the recess 28 of the tray 14. The foot 120 may be bifurcated by a keyway 134 configured to receive a portion of the anterior tab body 106. The keyway 134 may include one or more grooves or recesses 152 configured to receive corresponding keyway wings 150 on the anterior tab body 106. The foot 120 may include one or more rear tabs 136 positioned along a rear portion of the foot 120. The rear tabs 136 may be secured to the foot 120. The rear tabs 136 may be located on two lobes separated by the keyway 134. The posterior tabs 136 may each extend a length that extends in a direction generally parallel to the patient's coronal plane (e.g., a vertical, side-to-side extending plane). The posterior tabs 136 are receivable within corresponding posterior pockets or notches 44 of the tibial tray 14. The posterior tabs 136 may have a generally flat or planar upper surface 138 and a rounded or curved lower surface 139. The posterior tabs 136 may have a transition of the rounded bottom 139 to the flat upper portion 138 such that they are locked into the corresponding notch 44 of the tibial tray 14.

[0035] The foot 120 and the arm 124 may define an inner opening 130 configured to receive the front tab body 106. The opening 130 may be aligned generally transverse to the central longitudinal axis A of the instrument 10. For example, the opening 130 may be generally perpendicular to the central longitudinal axis A of the instrument 10. The arm 124 may define a shaft through hole 132 in fluid communication with the opening 130. The shaft hole 132 is configured to receive the rotatable shaft 108. As best seen in FIG. 20 , the shaft 108 may extend through the hole 132 in the arm 124 and through the front tab body 106, thereby anchoring and controlling movement of the front tab body 106.

[0036] 14 , the anterior tab body 106 includes a base 140 having an upwardly or proximally projecting tongue 142. The base 106 includes an anterior tab 144 positioned along a front portion of the anterior tab body 106. The anterior tab 144 may extend with a length that extends in a direction generally parallel to the patient's coronal plane (e.g., a vertical side-to-side extending plane). The anterior tab 144 may extend along the entire width of the anterior tab body 106. The anterior tab 144 is receivable within a corresponding anterior pocket or notch 46 of the tibial tray 14. The upper surface 145 of the anterior tab 144 may be flat or planar. The anterior tab 144 may have a squared or angled perimeter to lock into the notch 46 of the tibial tray 14. The upper portion 145 of the tab 144 may include a curved transition 147 that is generally concave along the length of the base 106. The geometry of the anterior tab 144 may correspond to the smallest tibial tray 14 (e.g., a 1T1F size tray). Because the geometry is similar among all trays 14, the anterior tab 144 is also configured to engage the anterior pocket 46 of all other tray sizes.

[0037] The tabs 136, 144 of the inserter 10 are configured to attach to all tray sizes in the set. When the smallest tray 14 (e.g., size 1T1F tray) is attached, the outer geometry of the tabs 134, 144 engages the pockets 44, 46. When the largest size tray 14 (e.g., size 6T6F tray) is attached, the inner geometry of the tabs 134, 144 engages the pockets 44, 46. Any pockets 44, 46 of tray sizes between the smallest and largest sizes can be engaged by the flats 138, 145 of the tabs 136, 144, which may be a similar feature across all tray sizes.

[0038] With further emphasis on FIG. 14 , a tang 142 of the front tab body 106 projects proximally and is receivable within the opening 130 of the arm 124 of the body 102 of the instrument 10. A through hole 146 is provided through the tang 142. The through hole 146 may be internally threaded with one or more threads 148 that correspond to the threads 162 of the shaft 108. The threads 148 of the through hole 146 act in conjunction with the rotation of the shaft 108, thereby allowing the tab body 106 to translate along a front-to-rear orientation. In one embodiment, the hole 146 is a triple-start lead threaded hole configured to interact with the triple-start shaft 108, thereby increasing the translational speed of the front tab body 106. Different combinations of thread types and single-start, double-start, or triple-start lead threads may be utilized to tailor the translational speed to desired specifications.

[0039] The front tab body 106 may include one or more keyway wings 150. In one embodiment, the base 140 includes a pair of keyway wings 150 projecting outward in opposite directions. The keyway wings 150 may extend laterally outward with a length extending in a direction generally parallel to the patient's coronal plane (e.g., a vertical side-to-side extending plane). Each keyway wing 150 may have a generally polyhedral body with polygonal faces and straight edges. For example, the keyway wings 150 may have a cuboid or rectangular shape, although it will be understood that other suitable shapes and configurations may be selected. The wings 150 may be sized and shaped to fit into corresponding grooves or recesses 152 defined in the foot 120 of the body 102. The keyway wings 150 may be positioned proximal to the front tab 144 and below the tongue 142. The keyway wings 150 are configured to mate with the keyways 134 in the body 102 to prevent angulation in the anterior-posterior direction while expansion is occurring. For example, the keyways 134 in the body 102 can prevent the front tab body 106 from angulating in a moment about the center of the three lead hole 146 in the anterior-posterior direction.

[0040] 15, the shaft 108 works in conjunction with the front tab body 106 to provide translational movement in the front-to-rear direction to accommodate all tray sizes. The shaft 108 includes a shaft body 160 having one or more threads 162 extending along its length. In an exemplary embodiment, the threads 162 include triple-start lead threads configured to mate with corresponding triple-start lead threads 148 of the bore 146 through the front tab body 106. Rotation of the shaft 108 causes the front tab body 106 to translate along the front-to-rear direction, thereby allowing the front tab 144 to engage the front pocket 46 in a locked configuration. Different combinations of thread types and single-start / double-start / triple-start lead threads can be utilized to adjust the translation speed to desired specifications. One end of the shaft 160 can have an enlarged knob 164 configured to be gripped by a user. The expansion knob 164 may have a rough knurled or other friction enhancing surface to assist the cleaning technician or surgeon in torqueing down and locking or unlocking the front tab 144 into position within the tray 14. At the opposite end of the shaft 160, near a tip 168, is a groove 166 where an outer retaining ring 170 is fastened after all parts are fully assembled to lock the assembly together.

[0041] 16, one or more plugs 180 may be configured to protrude slightly to ensure that the bottom flat 135 of the body 102 does not directly contact the proximal surface 22 of the tray 14. In one embodiment, the inserter 10 includes three plugs 180, two in the feet 120 on either side of the keyway 134 and one in the base 140 of the anterior tab body 106. The plugs 180 may be constructed from plastic to avoid metal-to-metal contact that may damage the tibial tray 14 and create undesirable stress risers. The plugs 180 may have a generally cylindrical body with a flat lower surface 182 configured to contact the proximal surface 22 of the plate 20 when the instrument 10 is received in the tray 14. The plastic plugs 180 may be press-fit into two holes 184 located in the body 102 and one hole 184 located in the anterior tab body 106. Each of the plastic plugs 180 may be secured with a dowel pin 186 that extends through an opening 188 in the plug body. For the front tab body 106, the pin 186 may be received through a transverse opening 154 in the base 140 of the front tab body 106. Similarly, each pin 186 may be received through a transverse opening 154 in the foot 120 of the body 102. Each dowel pin 186 may be inserted and fused flush to ensure that use of the inserter 10 does not result in loosening of the plugs 180 over time. In the embodiment shown, each dowel pin 186 may be permanently fixed.

[0042] When assembled, the anterior tab body 106 is inserted into the opening 130 and keyway 134 of the body 102. The anterior tab body 106 is allowed to translate within the opening 130 and keyway 134 along the anterior-posterior direction to expand the anterior tab 144 outwardly into the anterior pocket 46 of the tibial tray 14. The insert 172 may limit the total amount of relative translation of the anterior tab body 106. The shaft 108 is threaded into both bodies 102, 106 until fully expanded. The shaft 160 extends through the body 102 and the anterior tab body 106. The portion of the shaft 160 that contacts the body 102 may be non-threaded or threaded. The portion of the shaft 160 engaged with the anterior tab body 106 may be threadedly connected to the anterior tab body 106 to translate the anterior tab body 106. The shaft 108, and thus the front tab body 106, may be locked in place utilizing an external retaining ring 170. A first plug 180 may be inserted into an opening 184 through the lower surface of the base 140 of the front tab body 106, and a second and third plugs 180 may be inserted into their respective openings 184 through the lower surface 135 of the foot 120 of the body 102. Each of the plugs 180 may be secured in place by a dowel pin 186. The plugs 180 protrude downward or distally to prevent damage to the tray 14.

[0043] Figure 17 shows the front tab body 106, including the front tab 144, in a retracted or unlocked position. Figure 18 shows the front tab body 106, including the front tab 144, in an extended or locked position. As can be seen, the front tab body 106 can translate between the unlocked and locked positions through the keyway 134 in the body 102.

[0044] In the retracted position shown in FIG. 19, the anterior tab body 106 is positioned within the keyway 134 and is fully received within the foot 120 of the body 102. The tibial tray 14 is tilted upward to allow the fixed posterior tab 136 to engage the posterior notch 44 of the tibial tray 14. After the foot 120 of the body 102 is fully seated within the insert receiving space 28, the anterior tab 144 can be locked to the tray 14. When the shaft 108 is rotated as shown in FIG. 20, the anterior tab body 106 slides outward in the anterior direction. The keyway wings 150 of the anterior tab body 106 prevent anterior-posterior angulation while expansion is occurring. In the expanded position, the anterior tab body 106 protrudes outward, thereby allowing the anterior tab 144 to engage the anterior notch 46 of the tibial tray 14 and lock the inserter 10 to the tibial tray 14.

[0045] 22 illustrates retraction of the anterior tab body 106 and removal of the instrument 10 from the tray 14. The shaft 108 rotates in the opposite direction, thereby releasing the anterior tab 144 from the anterior notch of the tibial tray 14. The tibial tray 14 is tilted downward to release the fixed posterior tab 136 and free the instrument 10 from the tray 14. The anterior and posterior notches 44, 46 of the tibial tray 14 may now be similarly utilized to position the insert 16 within and lock it to the tibial tray 14.

[0046] 23-25 ​​show control over six degrees of freedom movement via the inserter 10. FIG. 23 shows a curved arrow around the handle 104 representing internal / external rotation and a straight arrow next to the tibial tray 14 representing proximal / distal translation. FIG. 24 shows a straight arrow next to the handle 104 representing anterior / posterior translation and a curved arrow next to the body 102 representing anterior / posterior angulation. FIG. 25 shows a straight arrow next to the handle 104 representing medial / lateral translation and a curved arrow next to the body 102 representing varus / valgus angulation. The lockable feature of the inserter instrument 10 relative to the tibial tray 14 allows control over six degrees of freedom movement and precise positioning of the tibial tray 14 during implantation.

[0047] Although the present invention has been described in detail and with reference to specific embodiments, it will be apparent to those skilled in the art that various changes and modifications can be made without departing from the spirit and scope of the present invention. Therefore, the present invention is intended to cover the modifications and variations of the present invention provided within the scope of the appended claims and their equivalents. For example, it is expressly intended that all of the elements of the various devices disclosed above can be combined or modified in any suitable configuration.

Claims

1. 1. A system for knee arthroplasty, comprising: a tibial tray having a peripheral wall defining an insert receiving space, the peripheral wall defining a pair of posterior notches and a single anterior notch; an inserter having a body having a pair of fixed posterior tabs, a movable anterior tab body having an anterior tab, and a rotatable shaft for controlling movement of the anterior tab body, wherein the posterior tabs are receivable in the posterior notch of the tibial tray and the anterior tab is receivable in the anterior notch of the tibial tray when the shaft rotates and the anterior tab body translates to an expanded position; the body of the inserter includes a foot having an upwardly projecting neck and a forwardly projecting arm, the foot being bifurcated by a keyway, the front tab body being receivable in the keyway; the front tab body includes a pair of keyway wings projecting outwardly in opposite directions, the keyways defining recesses configured to receive respective keyway wings thereby preventing anterior-posterior angulation while expansion is occurring.

2. The system of claim 1 , wherein the tibial tray has a kidney shape with an anterior side forming a lateral convex side and a posterior side including a medial concave side separating two lobes.

3. The system of claim 1 , wherein the tibial tray includes a keel attached to a distal surface of the tibial tray, the keel including a pair of coronal fins and at least one sagittal fin.

4. 2. The system of claim 1, wherein the inserter includes a plurality of plugs press-fit into the body and the front tab body, the plurality of plugs protruding from a bottom of the body, thereby ensuring that the body does not contact the insert receiving space of the tibial tray.

5. An inserter for implanting a tibial tray for knee arthroplasty, the tibial tray having a peripheral wall defining an insert-receiving space, the peripheral wall defining a pair of posterior notches and a single anterior notch, comprising: a body having a pair of fixed rear tabs; a movable front tab body having a front tab; a rotatable shaft for controlling movement of the front tub body; when the shaft rotates and the anterior tab body translates to an expanded position, the posterior tab is receivable in the posterior notch of the tibial tray and the anterior tab is receivable in the anterior notch of the tibial tray; the body includes a foot having an upwardly projecting neck and a forwardly projecting arm; the foot is bifurcated by a keyway, the front tab body is receivable in the keyway; the front tab body including a pair of oppositely outwardly projecting keyway wings, the keyways defining recesses configured to receive respective keyway wings and thereby prevent anterior-posterior angulation while expansion is occurring; Further comprising a handle, the body being coupled to the handle; the front tab is movable within the body and includes a threaded opening; an inserter, the shaft having a threaded portion that engages the threaded opening in the front tab, positioned through the body and the tab body, the tab body translating outwardly of the body as the shaft is rotated to a locked position.

6. The inserter of claim 5 , wherein the foot has a kidney bean profile.

7. The inserter of claim 5 , wherein the front tab body includes a base having an upwardly projecting tongue, the tongue defining the threaded opening.

8. 8. The inserter of claim 7, wherein the threaded opening is a triple start lead screw hole, and the shaft includes a triple start lead shaft configured to interact with the triple start lead screw hole to increase the translational speed of the front tab body.

9. The inserter of claim 7 , wherein the front tab is positioned along a front portion of the base, the front tab extending along an entire width of the front tab body.

10. The inserter of claim 5 , wherein the handle includes an elongate body terminating distally in a threaded end, the threaded end mating with corresponding threads on the body.

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