Patent Description:
Proper alignment of a replacement joint device, including components of the replacement joint device, often can contribute to attaining optimal wear resistance performance of the implanted device. Yet, anatomical variations present challenges in properly aligning the implant device for each patient. For example, during implant construct of knee replacement joints, challenges can arise with fitting a patient's intramedullary geometry with an implant, such as, for example, an intramedullary stem, while also fitting both the external geometry with a condylar replacing implant and the metaphyseal and/or diaphyseal geometry with an associated implant or augment component. Moreover, the addition of a metaphyseal and/or diaphyseal implant or augment to an implant construct often impairs the ability to adjustably fit the implant to the patient and/or attain proper alignment of the various components of the implant. Such difficulties can at times be attributed to the anatomy of the patient, the geometrical constraints of the implant, and/or constraints associated with the preparatory instrumentation. For example, geometrical constraints of the metaphyseal and/or diaphyseal implant or augment can include the inability to accommodate the placement or position of both the intramedullary stem and the condylar implant, which can attribute to difficulties in forming a junction mechanism for those, and possibly other, components of the implant.

Challenges associated with attaining proper alignment during implant construct that involves a metaphyseal and/or diaphyseal implant or augment may have, at times, been resolved by compromises in terms of the placement of at least some components of the implant device, such as, for example, the location of the condylar implant. Yet, such compromises can result in less than optimal bone coverage, which can potentially compromise loading of the construct to the cortical rim of the bone. Other compromises can include reducing the stem size in order to offset the stem position, with the area vacated by such offsetting being made up with cement. Yet, such compromises can adversely impact the life of the implant, and can be, at leastin part, attributable to failures relating to subsidence, loosening, stress-shielding factors, and increased stresses on the implant device, among other failures that are associated with compromised articulation positioning.

The integrity of the implant construct can therefore be adversely impacted if the bone is not shaped, during implant surgery, to accommodate the positioning of augmenting implants at locations in which the implanted augments, such as, for example, stems, sleeves, and cones, among other augments, will not interfere with the articular component and/or other augmenting implants. Yet, the different anatomies of patients often present challenges in the ability to position augmenting implants at optimal locations. For example, in order to achieve optimal bone coverage, the articular component stem connection (post) axis can need to be at a location that is different than the stem axis. Further, the inability to attain such positioning can lead to compromises in the structure, life span, and/or performance of the implanted device, among other compromises. <CIT> describes a locking instrument assembly for use in conjunction with an intramedullary device.

An aspect of the present application is an apparatus for use with a bone preparation device, the apparatus including a sleeve member that has a guide slot. Additionally, the guide slot has a central guide slot axis that is offset from a longitudinal sleeve axis of the sleeve member. The apparatus also includes a handle member that has an inner area that is sized to receive removable insertion of at least a portion of the sleeve member. The handle member also has a connection member that is structured to be coupled to the bone preparation device. The apparatus further includes a retention member that is adapted to selectively secure the sleeve member to the handle member at a selected one of a plurality of rotational positions, each of the plurality of rotational positions adjusting an angular position of at least the guide slot relative to a longitudinal handle axis of the handle member. The retention member includes a mating engagement between one or more projections such as pins of either the handle member and the sleeve member with one or more recesses such a retention openings of the other of the handle member and the sleeve member.

The bone preparation device has a sidewall that extends about a central cutting axis of the bone preparation device. The sidewall has an outer surface an inner surface, the outer surface being structured to facilitate displacement of bone material, and the inner surface defining an aperture in the bone preparation device. The bone preparation device also includes an upper wall that is adjoined to the sidewall. The upper wall has an opening that is in fluid communication with the aperture. The opening includes a pair of opposing recesses that are structured to extend a portion of a size of a portion of the opening. The opening further includes a slot that outwardly extends from one of the pair of opposing recesses. Additionally, the upper wall defines, in part, a cavity that is adjacent to an inner wall of the upper wall. The cavity is structured to extend a size of a portion of the aperture.

The description herein makes reference to the accompanying figures wherein like reference numerals refer to like parts throughout the several views.

The foregoing summary, as well as the following detailed description of certain embodiments of the present application, will be better understood when read in conjunction with the appended drawings in which like reference numbers indicate like features, components and method steps. For the purpose of illustrating the invention, there is shown in the drawings, certain embodiments. It should be understood, however, that the present invention is not limited to the arrangements and instrumentalities shown in the attached drawings.

Certain terminology is used in the foregoing description for convenience and is not intended to be limiting. Words such as "upper," "lower," "top," "bottom," "first," and "second" designate directions in the drawings to which reference is made. This terminology includes the words specifically noted above, derivatives thereof, and words of similar import. Additionally, the words "a" and "one" are defined as including one or more of the referenced item unless specifically noted. The phrase "at least one of" followed by a list of two or more items, such as "A, B or C," means any individual one of A, B or C, as well as any combination thereof.

<FIG> illustrates a front perspective view of a forming tool <NUM> for preparing a bone for implantation of an augment or other implant component (collectively referred to as "augment") according to an illustrated embodiment of the present application. The forming tool <NUM> includes a bone preparation device <NUM> that is selectively coupled to a distal end <NUM> of the forming tool <NUM>, as discussed below. As also discussed below in more detail, a proximal end <NUM> of the forming tool <NUM> is adapted to at least assist in selectively adjusting the location for forming a cut in a bone using the bone preparation device <NUM> at either, or both, a distance and direction away from one or more reference axis(es). The forming tool <NUM> is structured to receive insertion of, or otherwise engage, at least a portion of an orientation referencing instrument or guide <NUM>, such as, for example, a intramedullary rod, trial stem, reamer, or offset rod, among other guides, as shown in <FIG>. According to the example provided in <FIG>, the guide <NUM> is an intramedullary rod that extends along a longitudinal guide axis <NUM>, which may, or may not, be aligned with a longitudinal reference axis of the intramedullary canal <NUM> in the patient's bone <NUM>. Further, according to the illustrated embodiment, the bone preparation device <NUM> is adapted to form an augment opening <NUM> having a depth (as indicated by "X" in <FIG>) in the bone <NUM>. Further, the augment opening <NUM> is positioned about a central augment axis <NUM>, as shown for example, in <FIG>, and can be generally at the same location, or can be angularly and/or linearly offset from one or more axes, a reference axis, such as, for example, the longitudinal guide axis <NUM>.

As shown by at least <FIG> and <FIG>, according to the illustrated embodiment, the forming tool <NUM> includes a sleeve member <NUM> and a handle member <NUM>. The sleeve member <NUM> includes a guide body <NUM> and a selector body <NUM>. An outer wall <NUM> of the guide body <NUM> extends between opposing first and second ends 128a, 128b of the guide body <NUM>, the first end 128a being adjacent to the selector body <NUM>. The outer wall <NUM> of the guide body <NUM> can have a variety of shapes and sizes. For example, in the illustrated embodiment, at least a portion of the outer wall <NUM> has a generally elongated cylindrical shape that extends along a longitudinal sleeve axis <NUM> of the sleeve member <NUM>. The outer wall <NUM> can also form a hub portion <NUM> of the guide body <NUM> that extends from a lower portion <NUM> of the selector body <NUM>.

The guide body <NUM> includes a guide slot <NUM> that extends along at least a portion of the outer wall <NUM>, and which is sized to receive the insertion of at least a portion of the guide <NUM>. During operation of the forming tool <NUM> and/or the bone preparation device <NUM>, the guide <NUM> can be secured to the forming tool <NUM>, such as, for example, via use of a retaining mechanism, including, but not limited to, a threaded, slotted, or spring capture retaining mechanism, among others.

The guide slot <NUM> can have a variety of different shapes and sizes. For example, as depicted in at least <FIG> and <FIG>, according to certain embodiments, the guide slot <NUM>' can have a generally cylindrical shape. However, according to other embodiments, the guide slot <NUM> can have an elongated shape, as shown, for example, in at least <FIG> and <FIG>. The guide slot <NUM>, <NUM>' extends along a centrally located guide slot axis <NUM> The guide slot axis <NUM> is at least linearly offset, by varying distances, from the longitudinal sleeve axis <NUM> of the sleeve member <NUM>. For example, according to the embodiments illustrated in <FIG>, the sleeve members 118a, 118b, 118c can be configured to provide guide slots <NUM>' that each have different linear offset distances between the longitudinal sleeve <NUM> and the guide axis <NUM> and/or the guide axis slot <NUM>, as indicated by offset distances D<NUM>, D<NUM>, and D<NUM>, respectively. In the illustrated examples, linear offset distance D<NUM> is less than that of linear offset distance D<NUM>, which is less than linear offset distance D<NUM>. Thus, according to certain embodiments, the forming tool <NUM> can be modular in that sleeve members <NUM> having guide slots <NUM>, <NUM>' of different shapes, sizes, and/or positioning of the guide slot axis <NUM> relative to the longitudinal sleeve axis <NUM>, among other reference axes, can be interchangeably selected for operable engagement with the handle member <NUM>, and thus for use with the forming tool <NUM>.

Referencing <FIG>, according to certain embodiments, the guide slot <NUM> can extend through a portion of the outer wall <NUM> so as to provide the guide slot <NUM> with a depth that extends from an opening <NUM> of the guide slot <NUM> to a bottom portion <NUM> of the guide slot <NUM>. According to such an embodiment, the bottom portion <NUM> of the guide slot <NUM> can correspond to a portion of the outer wall <NUM>, with the bottom portion <NUM> and the opening <NUM> of the guide slot <NUM> being generally at opposing sides or ends of the guide slot <NUM>. Further, according to such embodiments, the depth of the guide slot <NUM> can allow for adjustments in the location of at least the guide <NUM> within the guide slot <NUM>, and thereby permit adjustments of the location of at least the guide <NUM> relative to the guide slot axis <NUM> and/or the longitudinal sleeve axis <NUM>. Further, according to certain embodiments, one or more sleeve members <NUM> can have guide slots <NUM> of different depths, thereby allowing for the selection of a guide body <NUM> that may, or may not, offset the guide <NUM> from at least the guide slot axis <NUM> by a predetermined or maximum distance.

Referencing <FIG>, the selector body <NUM> of the sleeve member <NUM> can include an aperture <NUM>, <NUM>' that is in fluid communication with the guide slot <NUM>, <NUM>'. According to certain embodiments, the aperture <NUM>, <NUM>' can have a shape that is generally similar to the shape, or is an extension, of the guide slot <NUM>, <NUM>', such as, for example, having a generally circular or elongated shape. However, the aperture <NUM>, <NUM>' of the selector body <NUM> can have a variety of other shapes. For example, according to the illustrated embodiment, the aperture <NUM>, <NUM>' can have a generally elongated shape, such as, for example, have a linear length (as indicated by "L" in <FIG>) that is generally aligned with or exceeds the size or depth of the guide slot <NUM>, <NUM>' so as to facilitate visual detection through the aperture <NUM>, <NUM>' and/or the position or location of the guide <NUM> in the guide slot <NUM>, <NUM>'.

An upper surface <NUM> of the selector body <NUM> can also include an indicator <NUM> that facilitates a determination of an angular orientation of at least the guide slot <NUM>, <NUM>', guide slot axis <NUM>, and/or the guide <NUM> relative to a reference axis, as discussed below. In the illustrated embodiment, the indicator <NUM> can include an indicium, such as, for example, a word or symbol, including, but not limited to, an arrow. Further, according to certain embodiments, the indicium can be positioned on an upper surface <NUM> of the selector body <NUM>, such as, for example, in a groove <NUM> within the upper surface <NUM>.

As shown by at least <FIG>, the handle member <NUM> has an inner area <NUM> that extends through the handle member <NUM>, at least a portion of the inner area <NUM> being sized to receive insertion of at least the guide body <NUM> of the sleeve member <NUM>. Further, a first end 154a of the handle member <NUM> can be adapted for selective locking engagement with the sleeve member <NUM>. For example, according to the illustrated embodiment, the sleeve member <NUM> and the handle member <NUM> can be adapted for selectively releasable locking engagement that prevents both axial and rotational displacement of the sleeve member <NUM> relative to the handle member <NUM>. For example, the forming tool <NUM> can include a lock member <NUM> that is adapted to retain the sleeve member <NUM> within the inner area <NUM> of the handle member <NUM> in a manner that can prevent axial displacement of the sleeve member <NUM> relative to the handle member <NUM>, while the selector body <NUM> of the sleeve member <NUM> is adapted for locking engagement with a selector hub <NUM> of the handle member <NUM>.

According to certain embodiments, the lock member <NUM> can be adapted to be displaceable between a first, locked position and a second, unlocked position. For example, according to certain embodiments, at least a portion of the lock member <NUM> can extend into at least the inner area <NUM> of the handle member <NUM> when the lock member <NUM> is in the first, locked position. According to certain embodiments, when the guide body <NUM> is inserted into the inner area <NUM> of the handle member <NUM>, the guide body <NUM> can engage the lock member <NUM> in a manner that displaces the lock member <NUM> from the first, locked position and to, and/or toward, the second, unlocked position. According to such embodiment, as the lock member <NUM> is displaced to and/or toward, the second, unlocked position, at least a portion of the lock member <NUM> can be withdrawn from, or otherwise displaced within, the inner area <NUM>. According to other embodiments, when the guide body <NUM> is to be inserted into the inner area <NUM>, the user can exert a force against an outer selector or button <NUM> of the lock member <NUM> that displaces at least a portion of the lock member <NUM> in and/or from the inner area <NUM> so that the lock member <NUM> does not prevent insertion of the guide body <NUM> into the inner area <NUM>. Further, with the guide body <NUM> positioned in the inner area <NUM>, the lock member <NUM> can be displaced toward, or to, the first, locked position so that the lock member <NUM> is positioned to engaged the guide body <NUM> in a manner that prevents the axial displacement of the sleeve member <NUM> relative to the handle member <NUM>. For example, a portion of lock member <NUM> can be received in a groove or recess in, or above a portion of, the hub portion <NUM> of the guide body <NUM> so as to prevent the axial displacement of the sleeve member <NUM> relative to the handle member <NUM>. According to such embodiments, when the guide body <NUM> is to be withdrawn from the inner area <NUM> of the handle member <NUM>, the user can exert a force against the outer selector or button <NUM> of the lock member <NUM> that displaces at least a portion of the lock member <NUM> toward or to the second, unlocked position, so that the lock member <NUM> is at a position that does not prevent the removal of the guide body <NUM> from the inner area <NUM>.

The handle member <NUM> is structured for selective, locking engagement with a portion of the sleeve member <NUM> so as to secure at least the angular position of the sleeve member <NUM> relative to the handle member <NUM>. For example, according to certain embodiments, a portion of the outer wall <NUM> of the sleeve member <NUM> and an inner wall <NUM> of the handle member <NUM> includes one or more protrusions, such as a retention member <NUM> that can comprise, for example, one or more mating splines, keys, or teeth that facilitate selective, locking engagement in a manner that permits the positioning, and, if necessary, re-positioning of the rotational position of the sleeve member <NUM> relative to the handle member <NUM>. According to certain embodiments, such mating splines can be positioned at, or around, the selector hub <NUM> portion of the handle member <NUM> and the selector body <NUM> of the guide body <NUM>.

As illustrated in <FIG>, according to other embodiments, the retention member <NUM> can be a pin that at least projects or extends at least from the lower portion <NUM> of the selector body <NUM> and is received in one or more recesses, such as retention openings <NUM> along the handle member <NUM>. A variety of different types of pins can be utilized for the projection member <NUM>, including, for example, a separate pin(s) that can be secured to the selector body <NUM> by a press fit, adhesive, or plastic weld, among other manners of attachment. Alternatively, the pin(s) can be a unitary, monolithic portion or extension of the selector body <NUM>. Further, the pin(s) can have a variety of different shapes and sizes, including having a generally circular or non-circular cross-sectional shape. Further, the shape and/or size of such a pin can be uniform or nonuniform as the pin extends away from the selector body <NUM>. Additionally, according to certain embodiments, at least a portion of the retention member <NUM> can be exposed or otherwise visible from or through the upper surface <NUM> of the selector body <NUM>. For example, according to certain embodiments, the retention member <NUM> can be positioned in an aperture <NUM> that extends through the selector body <NUM>, thereby exposing at least an end of the retention member <NUM> at the upper surface <NUM> of the selector body <NUM>. Such visual access to the retention member <NUM> from the upper surface <NUM> of the selector body <NUM> can allow the retention member <NUM> to also provide another indication of the angular orientation of the guide slot <NUM>, <NUM>' relative to the handle member <NUM>. Additionally, a visual indication of the angular location of the retention member <NUM> from the upper surface <NUM> of the selector body <NUM> can also facilitate positioning of the retention member <NUM> into locking engagement with a selected retention opening <NUM>.

Referencing <FIG>, an upper wall <NUM> at the first end 154a of the handle member <NUM> can include indicium that corresponds to one or more of the retention openings <NUM>. For example, in the illustrated embodiment, twelve retention openings <NUM> are positioned in a circular configuration about the upper wall <NUM> of the selector hub <NUM> and around, or adjacent to the opening <NUM> to the inner area <NUM>. Further, rotational position indicators <NUM> can correspond to the location of the retention openings <NUM>, which are identified in the depicted embodiment by a line and a corresponding number, namely, numbers "<NUM>" through number "<NUM>". However, a variety of other rotational positional indicators <NUM> can be employed. The rotational position indicators <NUM> can provide an indication of the rotational position of at least the guide slot <NUM>, <NUM>' and/or guide slot axis <NUM> relative to reference axis, such as, for example, the rotational position of the offset guide slot axis <NUM>, and/or the longitudinal sleeve axis <NUM>, among other reference axes.

The handle member <NUM> can also include a reference indicator <NUM> that can be structured for positioning and/or orientating at least the handle member <NUM> relative to a reference point, location, and/or direction, such as, for example, indicate a direction or orientation toward a particular portion of the bone <NUM> or another instrument, among other reference points. According to the illustrated embodiment, the reference indicator <NUM> can extend away from the selector hub <NUM> of the handle member <NUM>. Further, an end <NUM> of the reference indicator <NUM> can be configured to improve the ease at which the reference indicator <NUM> is positioned and/or orientated, or otherwise directed toward the reference point, location, and/or direction. For example, according to the illustrated embodiment, the reference indicator <NUM> can include a pair of opposing, converging end walls 180a, 180b that are joined together to generally form a point so as to provide the reference indicator <NUM> with a pointed or arrow-shaped configuration. Moreover, the point at the end <NUM> can provide a generally centralized area that can improve the ease at reference can be made to the reference point, location, and/or direction when orienting the position or location of at least the handle member <NUM>.

The selector body <NUM> can also be shaped or configured to facilitate the ability to grip or otherwise manipulate the position of the sleeve member <NUM>, such as, for example, the angular position of the sleeve member <NUM> relative to the handle member <NUM>. For example, according to the illustrated embodiment, an outer edge <NUM> of the selector body <NUM> can include a plurality of recesses <NUM> intermixed with a plurality of projections <NUM> that are structured to enhance the ability of a user to grasp, and/or retain a grasp of, the sleeve member <NUM>. Such a configuration of the recesses <NUM> and projections <NUM> can also form a knurled surface along the outer edge <NUM>.

A body portion <NUM> of the handle member <NUM> can extend between the selector hub <NUM> and a cutting assembly of the handle member <NUM>. According to the illustrated embodiment, the body portion <NUM> can include an outer wall <NUM> that has a generally cylindrical configuration that extends along a longitudinal handle axis <NUM>, as shown in <FIG>. When the sleeve member <NUM> is positioned within the inner area <NUM> of the handle member <NUM>, the longitudinal handle axis <NUM> and the longitudinal sleeve axis <NUM> can at least be parallel and/or generally aligned together. Additionally, the outer wall <NUM> along the body portion <NUM> can include a plurality of intermixed recesses <NUM> that provide protrusions <NUM> therebetween, which can improve the ease with which a user can securely grip and/or grasp the body portion <NUM>. Additionally, similar to other portions of the handle member <NUM>, the inner area <NUM> can extend through the body portion <NUM>. Further, according to the illustrated embedment, the inner area <NUM> along the body portion <NUM> can be sized to house at least a portion of the guide body <NUM> of the sleeve member <NUM>.

The cutting assembly can include an adjustable slide <NUM> that is adapted for axial displacement between first and second slide positions along a portion of the outer wall <NUM> of the handle member <NUM>. According to the illustrated embodiment, the adjustable slide <NUM> can include an outer slide wall <NUM> and an inner slide wall <NUM>, the inner slide wall <NUM> extending around at least a portion of the outer wall <NUM> of the handle member <NUM>. The outer slide wall <NUM> can generally define an outer periphery of the adjustable slide <NUM>. In the illustrated embodiment, the outer slide wall <NUM> extends along a hub portion <NUM> and a flange portion <NUM> of the adjustable slide <NUM>. The adjustable slide <NUM> can also include, or be coupled to, an engagement member <NUM> that is configured to be received in a slot or groove <NUM> in the bone preparation device <NUM>. According to certain embodiments, the engagement member <NUM> is a projection that extends from a lower surface or region of the adjustable slide <NUM> and extends to, or around, a region of a connection member <NUM> of the handle member <NUM>, as discussed below. Further, the engagement member <NUM> and adjustable slide <NUM> can be part of a single, monolithic, or unitary construction. Alternatively, the engagement member <NUM> can be secured to the adjustable slide <NUM> by a fastener <NUM>, such as, for example, by a pin or screw, among other fasteners.

According to certain embodiments, the adjustable slide <NUM> can be secured or biased in the first slide position, as illustrated for example in <FIG> and <FIG>. For example, according to certain embodiments, the cutting assembly can include a biasing element, such as, for example, a spring, that biases the adjustable slide <NUM> to the first slide position. Further, according to certain embodiments, the outer wall <NUM> of the handle member <NUM> and/or the inner slide wall <NUM> of the adjustable slide <NUM> can include retention projections that interfere with the ability of the adjustable slide <NUM> to be displaced away from the first slide position. Thus, when the adjustable slide <NUM> is to be displaced to the second slide position, a force can be directed upon the adjustable slide <NUM> that overcomes the force provided by the biasing element and/or retention projections, if any, so that the adjustable slide <NUM> can be displaced to the second position, as shown in <FIG>. Alternatively, according to other embodiments, the fastener <NUM> can be utilized to retain the adjustable slide <NUM> in the first position. Displacement of the adjustable slide <NUM> from the first slide position to the second slide position can displace the engagement member <NUM> to a position that does not interfere with at least the initial engagement of the bone preparation device <NUM> with the handle member <NUM>, as discussed below.

The handle member <NUM> can also include a static abutment <NUM> that can be position to limit the extent the adjustable slide <NUM> can be axially displaced away from the first slide position and/or control the location of the second slide position. For example, the static abutment <NUM> can radially extend a distance away from at least a portion of the outer wall <NUM> of the handle member <NUM> such that the static abutment <NUM> interferes with, or otherwise prevents, the passage of the adjustable slide <NUM> around or past the static abutment <NUM>. According to the illustrated embodiment, the static abutment <NUM> can have a generally cylindrical shape. However, the static abutment <NUM> can have a variety of other shapes and sizes. Additionally, according to certain embodiments, the flange portion <NUM> of the adjustable slide <NUM> can be sized to engage or otherwise abut against the static abutment <NUM> in a manner that prevents the passage of the adjustable slide <NUM> past the static abutment <NUM>. Further, according to certain embodiments, the static abutment <NUM> can also include a recess <NUM> that is adapted for connection to an ancillary component of the forming tool <NUM>, such as, for example, an alignment handle.

As shown in at least <FIG>, according to certain embodiments, at least a portion of the outer wall <NUM> around a second end 128b of the handle member <NUM> can include implantation indicia <NUM> relating to the position and/or orientation of at least the bone preparation device <NUM> in the bone. For example, according to certain embodiments, the implantation indicia <NUM> can be a gauge that provides information relating to the depth and/or angle at which the bone preparation device <NUM> has been inserted into the bone. The implantation indicia <NUM> can be provided in a number of manners, including, for example, as shown in <FIG>, as numeric values and/or visual indicators, such as lines or other graphical representations. More specifically, according to certain embodiments, the implantation indicia <NUM> can be a collection of numeric values that increase in <NUM> millimeter (mm) increments.

Referencing <FIG> and <FIG>, the second end 128b of the handle member <NUM> includes a connection member <NUM> that is adapted to releasably secure the bone preparation device <NUM> to the handle member <NUM>. A variety of different types of connection members <NUM> can be utilized, including, for example, a threaded connector that mates a threaded component to the bone preparation device <NUM>. According to the illustrated embodiment, the connection member <NUM> includes a pair of arms 224a, 224b that extend from the distal end of the outer wall <NUM>. The arms 224a, 224b can each include arm extensions 226a, 226b that each outwardly protrude from a base portion 228a, 228b of the arms 224a, 224b. Additionally, according to certain embodiments, at least a portion of the arms 224a, 224b, such as, for example, the base portion 228a, 228b, can be structured to at least partially deform, bend, or deflect at least when the arm extensions 226a, 226b are being inserted into an aperture <NUM> of the bone preparation device <NUM>. According to certain embodiments, the aperture <NUM> of the bone preparation device <NUM> can include an undercut <NUM> beneath an upper wall <NUM> of the bone preparation device <NUM> that receives the insertion of at least a portion of the arm extensions 226a, 226b. According to such an embodiment, when the arm extensions 226a, 226b are positioned in the aperture <NUM> of the bone preparation device <NUM>, an upper surface <NUM> of the arm extensions 226a, 226b can be at least positioned beneath at least a portion of the upper wall <NUM> of the bone preparation device <NUM>. Such positioning of the arm extensions 226a, 226b beneath the upper wall <NUM> of the bone preparation device <NUM> so as to at least assist in retaining a secure attachment or connection between the bone preparation device <NUM> and the handle member <NUM>. Further, according to the illustrated embodiment, the arms 224a, 224b can be positioned along the second end 154b of the handle member <NUM> at a location that is positioned away, or radially offset from, the location of the engagement member <NUM>. For example, according to certain embodiments, the engagement member <NUM> can be positioned at, in opposite directions, about <NUM> degrees from each of the arms 224a, 224b. However, the engagement member can be located at a variety of other positions relative to the arms 224a, 224b.

<FIG> illustrates a bone preparation device <NUM> that is structure for operable attachment to the connection member <NUM> of the forming tool <NUM> according to an illustrated embodiment of the present application. In the depicted embodiment, the bone preparation device <NUM> is a broach. However, a variety of other types of bone preparation devices <NUM> can be used with the forming tool <NUM>, including, for example, a reamer. In the depicted embodiment, the bone preparation device <NUM> includes a sidewall <NUM> having an outer surface <NUM> and an inner surface <NUM>, the outer surface <NUM> being adapted to facilitate displacement of the bone preparation device <NUM> into, and/or removal of, the surrounding bone <NUM>. Further, according to certain embodiments, the outer surface <NUM> of the bone preparation device <NUM> can symmetrically or asymmetrical extend about a central cutting axis <NUM>. According to the illustrated embodiment, during use, the central cutting axis <NUM> can be generally positioned in general alignment with the longitudinal handle axis <NUM> and/or the longitudinal sleeve axis <NUM>. Moreover, in the illustrated embodiment, the longitudinal handle and sleeve axes <NUM>, <NUM> can be generally aligned with each other to provide a forming axis <NUM> for the forming tool <NUM>, as shown in <FIG>.

At least the aperture <NUM> of the bone preparation device <NUM> can be configured to facilitate a secure connection between the connection member <NUM> and the bone preparation device <NUM>. According to the illustrated embodiment, the aperture <NUM> can be in fluid communication with an opening <NUM> of the upper wall <NUM> of the bone preparation device <NUM>, the opening <NUM> having one or more recesses 242a, 242b that are sized to receive placement of the arm extensions 226a, 226b into at least the aperture <NUM>. The extent to which the arm extensions 226a, 226b can be axially displaced into the aperture <NUM> can also be limited by an inner surface <NUM> of the aperture <NUM> and/or the length of the base portion 228a, 228b of the arms 224a, 224b. Further, according to the illustrated embodiment, a slot <NUM> can extend outwardly from at least one recess 242a, 242b in the upper wall <NUM>. The slot <NUM> is configured to receive insertion of at least a portion of the engagement member <NUM>. Further, the engagement of the engagement member <NUM> with the slot <NUM> can prevent rotational displacement of at least the handle member <NUM> relative to the bone preparation device <NUM>.

When the bone preparation device <NUM> is to be operably connected to the connection member <NUM>, the adjustable slide <NUM> can be displaced from the first slide position to the second slide position, as shown in <FIG>. With the adjustable slide <NUM> in the second slide position, the engagement member <NUM> can be displaced away from the connection member by a distance that does not interfere with the arm extensions 226a, 226b being inserted into a corresponding recess 242a, 242b. With the arm extension 226a, 226b in the corresponding recess 242a, 242b, the bone preparation device <NUM> can be rotatably displaced relative to the handle member <NUM>, or vice versa, such that the extension arms 224a, 224b enter into the undercut <NUM> portion of the aperture <NUM> beneath an inner wall <NUM> of the upper wall <NUM>, as shown in <FIG> and <FIG>, and thereby prevents the bone preparation device <NUM> from being separated from the connection member <NUM>. Further, such rotation can position the engagement member <NUM> at a location that, when the adjustable slide <NUM> is returned to the first slide position, at least a portion of the engagement member <NUM> is received in the slot <NUM> in the bone preparation device <NUM> so as to prevent, during use of the forming tool <NUM>, rotational displacement of the bone preparation device <NUM> relative to the handle member <NUM>.

In the illustrated embodiment, the bone preparation device <NUM> is a broach. According to such an embodiment, during shaping or forming of the bone <NUM>, an upper end of the forming tool <NUM> can be impacted by a tool, such as, for example, a mallet, that forces the bone preparation device <NUM> into the bone <NUM>. The forming tool <NUM> can continue to be impacted by the tool until the bone preparation device <NUM> attains a particular depth and/or a particular shape in the bone <NUM>. Further, upon attaining a particular depth or shape in the bone <NUM>, the bone preparation device <NUM> can be removed from the connection member <NUM> and replaced with a different sized bone preparation device <NUM>, such as a larger broach, and the process can be repeated until a particular size and/or shape is attained in the bone <NUM>.

While the above example of the forming tool <NUM> was discussed in terms of use with a bone preparation device <NUM>, a variety of other components can be attached to the forming tool <NUM> in a similar manner, including, but not limited to, trial components for the implant device. Additionally, according to certain embodiments, the bone preparation device <NUM> can be indirectly connected to the connection member <NUM>. For example, the connection member <NUM> can be connected to a first end of an extension or coupling in a similar manner as discussed above with respect to the bone preparation device <NUM>, with the bone preparation device <NUM> being attached to a second end of the extension or coupling. Additionally, according to certain embodiments, the proximal end <NUM> of the forming tool <NUM> is structured for coupling to another instrument that can assist in the formation of the augment opening <NUM>, including, for example, an oscillating saw or drill.

Referencing <FIG>, during use, the position of the guide <NUM>, and thus the longitudinal guide axis <NUM>, within the guide slot <NUM> can provide a reference axis for positioning the central cutting axis <NUM> and/or the central augment axis <NUM>, which can be at the same location, for forming the augment opening <NUM> in a bone via use of the forming tool <NUM>. As shown in <FIG>, in certain instances, the guide <NUM> can be positioned within the guide slot <NUM> so that the longitudinal guide axis <NUM> is generally positioned along the forming axis <NUM> of the forming tool <NUM>. Moreover, in such a situation, the longitudinal guide axis <NUM> can be positioned within the guide slot <NUM> at a position in which the augment opening <NUM> formed by use of the forming tool <NUM> is generally aligned with, or not offset from, the longitudinal guide axis <NUM>. Further, as previously mentioned, the longitudinal guide axis <NUM> can correspond to, among other axes, the central axis of an intramedullary canal which may, or may not, have previously been shaped for receipt of a stem of an implant device. However, according to other situations, the forming tool <NUM> can be positioned relative to the guide <NUM> such that the guide <NUM> that extends into the guide slot <NUM> is offset from the forming axis <NUM>. For example, as shown in <FIG>, at least the guide slot <NUM> can be structured so that the guide <NUM> can be linearly offset from the longitudinal sleeve axis <NUM>, which can be shared by the forming axis <NUM>, such that the forming tool <NUM> will form an augment opening <NUM> having a central augment axis <NUM> that is linearly offset to the left (as indicated by "O<NUM>" in <FIG>) of at least the longitudinal guide axis <NUM>. Similarly, as shown in <FIG>, during other uses, at least the guide slot <NUM> can be structured so that the guide <NUM> can be linearly offset from the longitudinal sleeve axis <NUM>, and thus the forming axis <NUM>, such that the forming tool <NUM> will form an augment opening <NUM> having a central augment axis that is literally offset to the right (as indicated by "O<NUM>" in <FIG>) of at least the longitudinal guide axis <NUM>. In the examples provided by <FIG>, the angular position of the longitudinal guide axis <NUM> relative to at least the longitudinal sleeve axis <NUM> and/or the forming axis <NUM> remains the same, as indicated, for example, by the indicator <NUM> of the selector body <NUM> remaining at the "<NUM>" position. However, as previously discussed, in additional to be linearly offset, as shown in <FIG>, the angular orientation of the position of at least the longitudinal sleeve axis <NUM> and/or the forming axis <NUM> relative to the longitudinal guide axis <NUM> can be adjusted by adjusting the orientation of the selector body <NUM>, and thus the guide slot <NUM>, relative to at least the selector hub <NUM>.

As previously discussed, <FIG> provide another embodiment of the forming tool <NUM> in which the guide slots <NUM>' of the sleeve member <NUM> are pre-set to provide a particular linear offset distance between at least the guide slot axis <NUM> and the longitudinal axis <NUM>, which in the illustrated embodiment can be positioned along, or shared by, the forming axis <NUM> and the handle axis <NUM>. Additionally, relative to the settings of the guide slots <NUM>' of the embodiment depicted in <FIG>, the examples provided by <FIG> also demonstrate the guide slot axes <NUM> being angularly offset from at least the longitudinal sleeve axis <NUM>. For example, not only are the guide slot axes <NUM> in <FIG> positioned at linear offset distances of D<NUM>, D<NUM>, and D<NUM>, the guide slot axis <NUM> are also angularly offset so that, in reference to <FIG>, the guide slot axis <NUM> are above and to the right of the longitudinal guide axis <NUM>. In the illustrated examples, such angular displacement is attained by setting the indicator <NUM> of the selector body <NUM> to the "<NUM>" position relative to the selector hub <NUM>, and thereby adjusting the angular location of the guide slot axis <NUM> relative to the longitudinal sleeve axis <NUM> and/or the forming axis <NUM>.

<FIG> illustrates a front view of an exemplary tibial implant <NUM> having a tibial tray <NUM>, a tibial augment <NUM>, and a stem <NUM>. A variety of different augments can be used for the tibial augment <NUM>, including, for example, a cone or sleeve augment, among other augments. As shown, according to illustrated example, the tibial tray <NUM> can include a central tray axis <NUM> that is offset from a central augment axis <NUM> of the tibial augment <NUM>. Similarly, the stem <NUM> can extend along a stem axis <NUM> that is offset from the central augment axis <NUM> and the tray axis <NUM>, the stem axis <NUM> and the tray axis <NUM> being on opposing sides of the central augment axis <NUM>.

<FIG> illustrate examples of use of a forming tool <NUM> having an elongated guide slot <NUM> similar to that depicted in <FIG> and <FIG> to alter the location of the central augment axis <NUM>, and thus the location of the tibial augment <NUM>, in the bone <NUM>, relative to at least the stem <NUM> and/or the tibial tray <NUM>. In the illustrated embodiment, adjustments in the positioning of the forming tool <NUM> that are provided by the size of the guide slot <NUM>, such as the linear length of the guide slot <NUM> (as indicated by "L" in <FIG>), can facilitate the location of the formed central augment axis <NUM> relative to either, or both, of the longitudinal stem axis <NUM> and tray axis <NUM>. Moreover, such adjustment of the location of the central augment axis <NUM> can impact the location of the associated tibial augment <NUM> and the stem <NUM> and/or tibial tray <NUM>. For example, as shown in <FIG>, the forming tool <NUM> can be oriented to position the central augment axis <NUM> at a generally central location between the longitudinal stem axis <NUM> and tray axis <NUM>. However, the elongated configuration of the guide slot <NUM> can provide the ability to linearly displace the position of the forming tool <NUM> in a first direction so as to decrease the distance between the central augment axis <NUM> and the stem axis <NUM>, or increase the distance between the central augment axis <NUM> and the tray axis <NUM>, as shown, for example, in <FIG>. Further, according to certain embodiments, the guide slot <NUM> can have a length that allows the central augment axis <NUM> to be positioned at a location where a portion of the tibial tray <NUM>, such as, for example, a tray stem <NUM>, can contact the tibial augment <NUM> at a first contact location <NUM>. Similarly, the elongated configuration of the guide slot <NUM> can provide the ability to linearly displace the position of the forming tool <NUM> in a second direction so as to decrease the distance between the central augment axis <NUM> and tibial tray axis <NUM>, or increase the distance between the central augment axis <NUM> and the stem axis <NUM>, as shown, for example, in <FIG>. Further, according to certain embodiments, the guide slot <NUM> can have a length that allows the central augment axis <NUM> to be positioned at a location where a portion of the stem <NUM> can contact the tibial augment <NUM> at a second contact location <NUM>.

<FIG> also illustrate use of the forming tool <NUM> to adjust the location of the central augment axis <NUM> relative to the tray axis <NUM> and stem axis <NUM>, but via use three sleeve members that are similar to the sleeve members <NUM> and guide slots <NUM>' shown in <FIG> and <FIG>. Moreover, the linear offset distance provided by each of the guide slots <NUM>' illustrated in <FIG> differ and/or the angular orientation is altered so as to vary the linear distance between the central augment axis <NUM> and the stem axis <NUM> and tibial tray axis. For example, <FIG> illustrates use of a sleeve member <NUM> having a guide slot <NUM>' that has a linear offset distance that is less than that shown for the guide slot <NUM>' associated with <FIG>. Accordingly, compared to the guide slot <NUM>' used in <FIG>, the guide slot <NUM>' associated with <FIG> has a linear offset distance such that, when used with the same angular orientation, brings the central augment axis <NUM> into closer proximity to the tibial tray axis <NUM>, and increases the distance between the central augment axis <NUM> and the stem axis <NUM>. Similar to <FIG>, the offset provided by the positioning of the guide slot <NUM>' can allow the central augment axis <NUM> to be positioned at a location where a portion of the stem <NUM> can contact the tibial augment <NUM> at a second contact location <NUM>. <FIG> illustrates use of a sleeve member <NUM> having a guide slot <NUM>' that provides the same or similar offset as provided by the guide slot <NUM>' shown in <FIG>, but with the angular position of the guide slot rotated approximately <NUM> degrees. Moreover, referencing <FIG>, the alignment of the central augment axis <NUM> relative to the stem axis <NUM> and/or tibial tray axis <NUM> shown in <FIG> may have been attained by aligning the indicator <NUM> of the sleeve member <NUM> at the "<NUM>" position, while of the alignment central augment axis <NUM> shown in <FIG> may have been attained by aligning the indicator <NUM> of the same sleeve member <NUM> in the "<NUM>" position. Thus, in this example, by altering the angular position of guide slot, compared to <FIG>, the central augment axis <NUM> is extended further from the tibial tray axis <NUM>, and the distance between the central augment axis <NUM> and the stem axis <NUM> is decreased. Further the guide slot <NUM>' shown in <FIG> can, similar to <FIG>, provide a linear offset distance that allows the central augment axis <NUM> to be positioned at a location where a portion of the tibial tray <NUM>, such as, for example, a tray stem <NUM>, can contact the tibial augment <NUM> at the first contact location <NUM>.

Claim 1:
An apparatus (<NUM>) for use with a bone preparation device (<NUM>), the apparatus comprising:
a sleeve member (<NUM>) having a guide slot (<NUM>), the guide slot having a central guide slot axis (<NUM>) that is offset from a longitudinal sleeve axis (<NUM>) of the sleeve member (<NUM>);
a handle member (<NUM>) having an inner area (<NUM>) sized to receive removable insertion of at least a portion of the sleeve member (<NUM>), the handle member having a connection member (<NUM>) structured to be coupled to the bone preparation device (<NUM>); and
a retention member (<NUM>) adapted to selectively secure the sleeve member to the handle member (<NUM>) at a selected one of a plurality of rotational positions, each of the plurality of rotational positions adjusting an angular position of at least the guide slot (<NUM>) relative to a longitudinal handle axis (<NUM>) of the handle member (<NUM>), and
wherein the retention member (<NUM>) includes a mating engagement between one or more projections (<NUM>) of either the handle member (<NUM>) and the sleeve member (<NUM>) with one or more recesses (<NUM>) of the other of the handle member (<NUM>) and the sleeve member (<NUM>).