Orthopedic Implant Preparation System

Abstract

To provide a system for orthopedic implantation preparation, capable of positioning augmenting implants at optimal locations.SOLUTION: The present invention relates to a forming tool for use with a bone preparation device to form an opening or shape in a bone, such as, an opening for an augment of an orthopedic implant device. The forming tool can include a guide slot that extends through an outer wall of the forming tool, the guide slot being symmetrical or asymmetrical in its cross sectional shape. The guide slot is adapted to axially receive insertion of a guide that can be structured for placement in an intramedullary canal of a bone of a patient. Additionally, the guide slot can be sized to accommodate linear, angular, and / or rotational displacement of the forming tool about the received guide in a manner that can offset at least a position of the opening formed in the bone relative to one or more reference axes.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] Embodiments of the present application generally relate to preparation tools for embedding orthopedic implants or components in bone. More particularly, but not by way of limitation, embodiments of the present application relate to tools for implantation procedures of metaphyseal implants or augments and / or diaphyseal implants or augments with selectively constrained degrees of freedom relative to one or more reference axes. [Background technology]

[0002] Proper alignment of a replacement joint system including multiple components can often contribute to achieving optimal wear performance of the implanted joint system. However, anatomical differences present several challenges in properly aligning the implant joint system for an individual patient. For example, during implant construction of a knee replacement joint, challenges may arise with engaging the patient's intramedullary shape, e.g., intramedullary stem, with the implant, while challenges may arise with engaging both the external geometry with a condylar replacement implant and the metaphyseal and / or diaphyseal shape with the associated implant or augment components. Furthermore, adding metaphyseal and / or diaphyseal implants or augments to the implant components often impairs the ability to adjustably fit the implant to the patient and / or achieve proper alignment of the various components of the implant. Such difficulties are sometimes attributed to the patient's anatomy, the geometric constraints of the implant, and / or the constraints associated with the preparation tools. For example, the geometric constraints of metaphyseal and / or diaphyseal implants or augments may include an inability to accommodate the placement or position of both intramedullary stem and condylar implants, which may result from difficulties in forming the attachment mechanisms of those or other implant components.

[0003] The challenge of achieving proper alignment during implant construction involving metaphyseal and / or diaphyseal implants or augments has sometimes been resolved by compromising on the placement of at least some components of the implant device, for example the position of the condylar implant. However, such compromises may not meet optimal bone coverage, potentially compromising the fit of the construct to the cortical margin of the bone. Other compromises include reducing the size of the stem to offset the stem position, which is then repaired with cement. However, such compromises are believed to negatively impact the life of the implant and are at least partially attributable to failures related to subsidence, loosening, stress shielding factors, and increased stress on the implant device, among other failures associated with compromised joint positioning.

[0004] Thus, a complete implant construct may be adversely affected if the bone is not shaped during the implant surgery to accommodate the positioning of the implanted augments, such as stems, sleeves, and cones, among others, in a location that does not interfere with the glenoid component and / or other augmentation implants. However, challenges often exist with the ability to position the augmentation implants in optimal locations with respect to various patient anatomy. For example, to achieve optimal bone coverage, the stem connection (post) axis of the glenoid component may need to be at a different location than the stem axis. Furthermore, the inability to achieve such positioning may lead to compromises in the structure, life span, and / or performance of the implanted device, among other compromises. Summary of the Invention [Means for solving the problem]

[0005] One aspect of the present application relates to a formation tool having an outer wall with a distal end and a proximal end, the distal end having a connecting member adapted to couple the formation tool to a bone preparation device configured to facilitate displacement of bone material. The formation tool further includes a guide slot extending through the outer wall. The guide slot is sized to receive axial insertion of a guide configured for placement within the intramedullary canal. Additionally, the guide slot has a guide slot axis and is shaped to linearly move the formation tool about the received guide in one or more directions perpendicular to a longitudinal axis of the formation tool.

[0006] Another aspect of the present application relates to a formation tool having an outer wall including a connecting member adapted to couple the formation tool to a bone preparation device to facilitate displacement of bone material. The formation tool further includes a guide slot extending through the outer wall, the guide slot being asymmetric in cross-sectional shape along a guide slot axis of the guide slot. Additionally, the guide slot is sized to receive axial insertion of a guide configured for placement within the intramedullary canal.

[0007] Another aspect of the present application relates to a formation tool having a guide slot extending through an outer wall of the formation tool, the guide slot being asymmetric in cross-sectional shape along a guide slot axis of the guide slot. The guide slot is adapted to receive axial insertion of a guide configured to be positioned within the medullary canal. Additionally, the guide slot is sized to linearly displace the formation tool about the received guide in one or more directions perpendicular to a longitudinal axis of the formation tool. The formation tool also includes a bone preparation device coupled to the outer wall by a connecting member, the bone preparation device configured to displace bone material.

[0008] In describing this specification, reference should be made to the accompanying drawings, in which like reference characters refer to like parts throughout the several views, and in which: [Brief description of the drawings]

[0009] [Figure 1] FIG. 1 is a front perspective view of a formation tool for preparing bone for an implant procedure of an augment or implant device according to an illustrated embodiment of the present application. [Diagram 2] FIG. 1 is a front perspective view of a directional reference instrument or guide extending along a guide axis and inserted into a patient's intramedullary canal. [Diagram 3] 3 is a front perspective view of at least a portion of the guide shown in FIG. 2 positioned within the forming tool shown in FIG. 1. [Figure 4A] 2 is a side perspective view of the formation tool shown in FIG. 1 without a bone preparation device and having at least a first exemplary shape for the guide slots that corresponds to symmetric positioning of the formation tool. [Figure 4B] 4B is a cross-sectional view of the formation tool shown in FIGS. 3 and 4A having limited positional freedom and positioned across the tibia and around a reference guide or instrument. FIG. [Figure 4C] 13 is a cross-sectional view of a formation tool having asymmetric positional degrees of freedom positioned across the tibia and around a reference guide or instrument. [Figure 4D] 13 is a cross-sectional view of a formation tool with symmetric positional degrees of freedom positioned across the tibia and around a reference guide or instrument. [Figure 5A] 2 is a side perspective view of the formation tool shown in FIG. 1 without a bone preparation device and having at least a second exemplary shape of the guide slot that accommodates asymmetric positioning of the formation tool. [Figure 5B] FIG. 5B is a second end view of the forming tool shown in FIG. 5A. [Figure 6A] 2 is a side perspective view of the formation tool shown in FIG. 1 without a bone preparation device and having at least a third exemplary shape of the guide slot that accommodates asymmetric positioning of the formation tool. [Figure 6B] FIG. 6B is a second end view of the forming tool shown in FIG. 6A. [Figure 7A]10 is a side perspective view of the formation tool shown in FIG. 1 without a bone preparation device and having at least a fourth exemplary shape of the guide slot that accommodates asymmetric positioning of the formation tool. [Figure 7B] FIG. 7B is a second end view of the forming tool shown in FIG. 7A. [Figure 8] 1 illustrates an exemplary bone preparation device according to an illustrative embodiment of the present application. [Figure 9A] FIG. 1 is a perspective view of a first exemplary femoral implant including a femoral component, an augment, and a stem. [Figure 9B] FIG. 9B is a cross-sectional view taken along line 9B-9B of FIG. 9A, illustrating the asymmetric degree of freedom of the augment relative to the stem. [Figure 9C] FIG. 9C is a cross-sectional view taken along line 9C-9C of FIG. 9A, illustrating the asymmetric degree of freedom of the augment relative to the stem. [Figure 10A] 1 illustrates a front perspective view of an exemplary tibial implant including a tibial tray, an augment, and a stem. [Figure 10B] 10B is a cross-sectional view taken along line 10B-10B of FIG. 10A showing asymmetric degrees of freedom for the stem and tibial components. [Figure 10C] 10B illustrates a bottom view of the exemplary tibial implant shown in FIG. 10A. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] 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 accompanying drawings, in which like reference numerals indicate like features, components and method steps. For the purpose of illustrating the invention, there are shown in the drawings certain embodiments. It should be understood, however, that the invention is not limited to the arrangements and instrumentality shown in the accompanying drawings.

[0011] Certain terminology has been used in the above description for convenience and without limitation. Words such as "top," "bottom," "upper," "lower," "first," and "second" refer to directions as referenced in the drawings. This term includes the words specifically mentioned above, derivatives thereof, and words of similar import. Furthermore, the words "a" and "one" are defined as including one or more of the referenced item unless otherwise noted. The phrase "at least one" followed by a list of two or more items, such as "A, B, or C," refers to each one of A, B, or C, as well as combinations thereof.

[0012] FIG. 1 illustrates a front perspective view of a formation tool 100 for preparing bone for implanting an augment or implant device (collectively referred to as an "augment") according to an exemplary embodiment of the present application. The formation tool 100 includes a bone preparation device 102 selectively coupled to a distal end 104 (FIG. 4A) of the formation tool 100, as described below. The formation tool 100 also includes a proximal end 106 configured to engage an implant procedure tool, such as a proximal end 106 configured to be struck or impacted by, for example, a hammer or mallet. Alternatively, the proximal end 106 is configured to be coupled to another instrument that may aid in the formation of an augmentation opening in bone, including, for example, an oscillating saw or drill.

[0013] The formation tool 100 is configured to receive or engage insertion of at least a portion of a directional reference instrument or guide 108, such as an intramedullary rod, trial stem, reamer, or offset rod, among other guides, as shown in Figures 2 and 3. According to the example shown in Figures 2 and 3, the guide 108 is an intramedullary rod extending along a guide axis 110, which may or may not be generally aligned with a longitudinal axis 111 of an intramedullary canal 112 in the patient's bone 115. Furthermore, according to the illustrated embodiment, the bone preparation device 102 is adapted to form an augmentation opening 114 having a depth (indicated by an "X" in Figure 2) in the bone 115. Additionally, the augment openings 114 are positioned about the central augment opening 116, for example as shown in FIG. 2, and may be generally co-located with or angularly and linearly offset from a reference axis, such as the guide axis 110, the longitudinal axis 111 of the intramedullary canal 112, and / or one or more other axes of the implant device or its components.

[0014] According to the illustrated embodiment, the proximal end 106 of the formation tool 100 includes one or more platforms 118a, 118b configured to be impacted during formation of the augment opening 114. Moreover, in the illustrated embodiment, the pair of platforms 118a, 118b extend outwardly from a longitudinal axis 126 (FIG. 1) of the formation tool 100 along a platform axis 128 (FIG. 5B) that is generally perpendicular to the longitudinal axis 126 of the formation tool 100. According to such an embodiment, the ends 130a, 130b of the platforms 118a, 118b may be spaced apart a distance that provides the platforms 118a, 118b with an overall linear length that can increase the size of the area that allows an implant treatment tool, such as a mallet, to impact or engage the formation tool 100. It should be noted that the platforms 118a, 118b may have a variety of other shapes and configurations including, for example, circular, non-circular, round, or triangular shapes, among other shapes and / or shape segments.

[0015] According to the illustrated embodiment, the platform 118a, 118b includes an upper surface 120a, 120b configured to directly or indirectly impact or hit an implantation tool. The peripheral wall 122a, 122b of the platform 118a, 118b can extend from the upper surface 120a, 120b to the lower surface 124a, 124b of the platform 118a, 118b. Furthermore, the platform 118a, 118b can have a predetermined thickness that helps facilitate the platform 118a, 118b to withstand an impact force applied to at least the platform 118a, 118b by a striking device. The platform 118a, 118b may also include an opening 132 in fluid communication with and / or an extension of a guide slot 134 extending through at least a portion of the forming tool 100, as shown at least in FIG. 3 and described below. In the illustrated embodiment, the opening 132 can provide a user with visual access to the guide slot 134 to indicate the position of at least a portion of the forming tool 100 relative to at least the guide 108 and / or the guide axis 110 .

[0016] The forming tool 100 includes an outer wall 136 extending between at least the platforms 118a, 118b and the distal end 104 of the forming tool 100. Additionally, the outer wall 136 may or may not have a single, integral structure. Additionally, according to certain embodiments, the size and shape of the outer wall 136 may vary along various portions of the forming tool 100. For example, according to the illustrated embodiment, the first section 138 of the forming tool 100 may extend from the lower surfaces 124a, 124b of the platforms 118a, 118b to the second section 140 of the forming tool 100. In the illustrated embodiment, the first section 138 of the forming tool 100 may be generally configured to enhance a user's ability to grip or hold the forming tool 100. Thus, in the illustrated embodiment, the first section 138 may include a pair of opposing first walls 142a, 142b connected to one another by a pair of opposing second walls 144a, 144b. The first walls 142a, 142b and the second walls 144a, 144b can have a variety of shapes and sizes. For example, with reference to FIG. 1, according to certain embodiments, the opposing first walls 142a, 142b can have a generally flat or generally straight shape extending along a plane generally parallel to the longitudinal axis 126 of the forming tool 100. Furthermore, according to certain embodiments, the second walls 144a, 144b can extend along a predetermined radius such that the second walls 144a, 144b have a curved or at least partially rounded shape. It is noted that the first section 138 of the outer wall 136 can have other similar or different shapes, other similar or different sizes, and other similar or different configurations.

[0017] 3, according to certain embodiments, the first section 138 of the outer wall 136 can include one or more orifices 146a, 146b extending along a portion of the first section 138 and through the first walls 142a, 142b. Additionally, according to the illustrated embodiment, the orifices 146a, 146b can each extend along multiple parallel or non-parallel orifice axes. The multiple orifice axes are perpendicular to the longitudinal axis 126 of the forming tool 100. Furthermore, the orifices 146a, 146b can be located in a variety of other locations in addition to or instead of being positioned in the first section 138 of the outer wall 136, including, for example, extending through the second section 140. Additionally, the orifices 146a, 146b can have a variety of shapes and sizes. Furthermore, such orifices 146a, 146b are connected to facilitate the user's ability to measure the position of the formation tool 100 relative to a reference indicator or reference axis, such as (but not limited to) the relative position of the formation tool 100 relative to the intramedullary canal 112, the guide 108 and / or the guide axis 110.

[0018] According to certain embodiments, the second section 140 of the outer wall 136 can extend from the first section 138 generally toward the distal end 104 of the forming tool 100. The second section 140 may or may not have a similar size and shape as the first section 138. For example, according to the illustrated embodiment, the second section 140 can have a generally cylindrical shape of uniform or non-uniform shape or size. Alternatively, the second section 140 or a portion of the second section 140 can be removed, and instead, the first section 138 of the outer wall 136 can generally extend to at least the connecting member portion 146 of the forming tool 100, as illustrated in FIG. 4A. Conversely, according to other embodiments, the first section 138 of the outer wall 136 or a portion of the first section 138 can be removed and / or replaced with the second section 140 of the outer wall 136.

[0019] The connecting member 146 of the formation tool 100 can be configured to be directly or indirectly coupled to the bone preparation device 102. Additionally, the connecting member 146 can be provided with a variety of different configurations that can be utilized to securely couple the connecting member 146, and thus the formation tool 100, to the bone preparation device 102. For example, as shown in at least FIG. 4A and FIG. 8, the connecting member 146 can include male threads configured to mate with female threads in an opening 148 of the bone preparation device 102. According to other embodiments, the connecting member 146 and bone preparation device 102 can be connected or pressed into a slot in the bone preparation device 102 via insertion of a key or other protrusion from the formation tool 100. According to other embodiments, the connecting member 146 and bone preparation device 102 can be coupled together by a spring gripping mechanism or other biasing or retaining mechanism.

[0020] The formation tool 100 includes a guide slot 134 extending through at least a portion of the formation tool 100. The guide slot 134 is sized to at least accommodate insertion of at least a portion of the guide 108. As shown in FIG. 4B, according to certain configurations, the guide slot 134a can have a similar cross-sectional size and / or shape as the guide 108. Further, as shown in FIG. 4B, according to certain embodiments, the guide slot 134a can have a similar size as the guide 108, e.g., an inner diameter similar to an outer diameter of the guide 108, such that the guide slot 134a can accommodate insertion of the guide 108 and allow limited displacement of the formation tool 100 about the inserted guide 108. Thus, such similarity in shape and / or size of the guide slot 134a and the guide 108 limits or limits adjustment of the location where the augment opening 114 is formed in the bone 115 by use of the formation tool 100.

[0021] 4A, 4C and 4D, according to other embodiments, the guide slots 134b, 134b' can have a size and / or shape that allows adjustment of the position of the formation tool 100 relative to the position of at least the inserted guide 108, and thus the position at which the augment opening 114 can be formed in the bone 115; for example, FIGS. 4A and 4D show a formation tool 100 including a guide slot 134b having a shape similar to or larger than the guide slot 134a shown in FIG. 4B. This increased size of the guide slot 134b can provide increased and / or increased freedom for symmetrical displacement of the formation tool 100 about the inserted guide 108, thereby providing increased and / or increased freedom for changing the position of at least the bone preparation device 102, and thus the augment opening 114, relative to at least the guide 108. Thus, while the smaller diameter guide slot 134a shown in FIG. 4B can generally prevent at least the position of the formation tool 100 from being changed relative to the guide 108, the larger diameter guide slot 134b shown in FIGS. 4A and 4D can allow the formation tool 100 to move in a variety of different directions around the guide 108, thereby allowing adjustment at least in the position at which the augment opening 114 can be formed in the bone 115 using the formation tool 100.

[0022] 4C and 4D show asymmetric and symmetric guide slots 134b, 134b' sized to allow displacement of forming tool 100 so that guide 108 can be positioned, for example, generally at the lower left portion of guide slot 134b, 134b. According to such an example, unlike guide slot 134a shown in FIG. 4B, the shape and / or size of guide slots 134b, 134b' shown in FIG. 4C and 4D allows displacement of forming tool 100 so that longitudinal axis 126 of forming tool 100 can be offset from guide axis 110 of guide 108 along at least two of the other axes (indicated by the "X" and "Y" directions in FIG. 4C) and multiple directions involving these axes (X, Y). 4D, in this exemplary embodiment, such freedom of movement allows the formation tool 100 to be positioned such that the guide 108 contacts the inner wall 148 of the bone preparation device 102, thereby increasing the distance between the guide 108 and the opposing surface of the inner wall 148. Furthermore, such positioning allows the augment to be implanted in a position where it contacts other components of the implant device, such as, for example, contacting a tibial stem and / or a tray stem extending from a tibial tray.

[0023] According to certain embodiments, the guide slots 134 allow for some angular adjustment or displacement of the forming tool 100 (as illustrated by the "Z" direction in FIG. 4C) in addition to displacement along at least two axes (X, Y) and combinations thereof. Such angular displacement can, at least in certain circumstances, cause at least the longitudinal axis 126 of the forming tool 100 and / or the central augment axis 116 of the resulting augment opening 114 to become non-parallel relative to at least the guide axis 110 of the guide 108.

[0024] 5A-7B show the forming tool 100 having guide slots 134c-e with various shapes and sizes that can accommodate and / or limit the displacement of the forming tool 100 about the guide 108. For example, FIGS. 5A-5B show the guide slot 134c having a generally triangular or three-sided shape. In the orientation shown in FIG. 5B, the guide slot 134c is asymmetrical with respect to a transverse centerline 150 that is perpendicular to the longitudinal axis 126 of the illustrated forming tool 100 and generally parallel to the platform axis 128. It should be noted that the transverse centerline 150 can be located in various positions and / or orientations, including, for example, offset from the longitudinal axis 126 and / or the platform axis 128. Furthermore, according to certain embodiments, the transverse centerline 150 may not be perpendicular to the longitudinal axis 126 of the illustrated forming tool 100 and / or may be non-parallel to the platform axis 128.

[0025] In the configuration shown in FIGS. 5A and 5B, the first side 152 of the guide slot 134c relative to the transverse centerline 150 b 152 opposite the guide slot 134c. a 5B )。 Conversely, the opposite second side 152 may be configured to accommodate linear displacement of the forming tool 100 about the guide 108 at least along a first axis to a greater extent than the opposite second side 152 may accommodate linear displacement of the forming tool 100 about the guide 108 at least along a first axis (denoted by "X" in FIG. 5B ). a 1, on the first side 152 of the guide slot 134c. b The triangular shape of the guide slot 134c allows the first and second sides 152 of the guide slot 134c to be sized to accommodate a greater degree of linear displacement of the forming tool 100 about the guide 108 along at least a second axis that is at least different (denoted as "Y" in FIG. 5B) than the linear displacement of the forming tool 100 about the guide 108 along at least a second axis that is at least different (denoted as "Y" in FIG. 5B) that the triangular shape of the guide slot 134c allows the first and second sides 152 of the guide slot 134c to be sized to accommodate a greater degree of linear displacement of the forming tool 100 about the guide 108 along at least a second axis that is at least different (denoted as "Y" in FIG. 5B). b , 152 aThe guide slot 134c may be configured to accommodate varying degrees of linear displacement of the forming tool 100 about the guide slot 134c along a combination of the second axes (X, Y). Similarly, varying shapes and / or sizes of the guide slot 134c may allow the first and second sides 152 of the guide slot 134c to be aligned in a substantially parallel fashion. b , 152 a allows for varying degrees of rotational displacement of the forming tool 100 about the guide 108.

[0026] Similar to FIGS. 5A and 5B, the tapered guide slot 134d shown in FIGS. 6A and 6B and the intersecting circles of different sizes of the guide slot 134e in FIGS. 7A and 7B provide first and second sides 152 relative to the transverse centerline 150 that can accommodate varying degrees of linear and / or rotational displacement of the forming tool 100 relative to the guide 108. b , 152 a can be provided.

[0027] Alternatively, according to other embodiments, the guide 108 can be configured to accommodate insertion of at least a portion of the forming tool 100. According to such alternative embodiments, the guide 108 can include an opening to accommodate insertion of at least a portion of the forming tool 100, the opening being configured to limit the degrees of freedom of linear and / or rotational displacement, whether symmetric or asymmetric, of at least the forming tool 100 relative to the guide 108.

[0028] FIG. 8 illustrates an exemplary bone preparation device 102 configured to be operably attached to a connecting member 146 of a formation tool 100 according to an illustrated embodiment of the present application. In the illustrated embodiment, the bone preparation device 102 is a broach. According to such an embodiment, the proximal end 106 of the formation tool 100 is engageable by a tool struck by a mallet, such as the bone preparation device 102 being driven into the bone 115. The formation tool 100 can remain engaged by the tool until the bone preparation device 102 reaches a particular depth and / or a particular shape is obtained in the bone 115. Furthermore, upon achieving a particular depth and / or shape of the bone 115, the bone preparation device 102 is removed from the connecting member 146 and replaced with a different size bone preparation device 102, such as a larger broach. This process may be repeated until a particular size and / or shape is achieved in the bone 115. It should be noted that a variety of different types of bone preparation devices 102 other than pulp needles can also be used with the preparation tool 100 including, for example, files, reamers, or other cutting instruments.

[0029] In the illustrated embodiment, the bone preparation device 102 includes an outer surface 154 adapted to facilitate movement of the bone preparation device 102 to and / or removal of the bone preparation device 102 from the surrounding bone 115. Furthermore, according to certain embodiments, the outer surface 154 of the bone preparation device 102 can extend symmetrically or asymmetrically about a central cutting axis 154 of the bone preparation device 102. According to the illustrated embodiment, during use, the central cutting axis 154 may be disposed generally along the longitudinal axis 126 of the formation tool 100.

[0030] The aperture 148 of the bone preparation device 102 can be configured to facilitate a secure connection between the connecting member 146 and the bone preparation device 102. According to the illustrated embodiment, the aperture 148 can include female threads adapted to mate with the male threads of the connecting member 146. It is noted that the connecting member 146 and the bone preparation device 102 can be coupled together directly or indirectly in a variety of other ways, including, for example, slotted structures, spring-gripping structures, or biasing structures, among other retention components. Additionally, while the above example of the formation tool 100 is described with respect to use with the bone preparation device 102, a variety of other components, including, but not limited to, trial components for an implant device, can be attached to the formation tool 100 in a similar manner.

[0031] 9A shows a perspective view of an exemplary femoral implant 158 ​​including a femoral component 160, a femoral augment 162, and a stem 164. A variety of different augments can be used for the femoral augment 162, including, for example, a cone or sleeve augment, among other augments. As shown in FIG. 9A, according to the illustrated example, the stem 164 can extend along a stem axis 166. Additionally, the femoral implant 158 ​​can be configured and arranged such that the stem axis 166 may or may not be offset from a central augment axis 168 of the femoral augment 162.

[0032] Figure 9B, a cross-sectional view taken along line 9B-9B in Figure 9A, shows an example of an asymmetric positional degree of freedom in the implant position of the femoral augment 162 relative to the stem 164, made visible using line 9C-9C in Figure 9A, and Figure 9C shows an example of an asymmetric positional degree of freedom in the implant position of the femoral augment 162 relative to the stem 164 and femoral component 160, such as the femoral stem of the femoral component 160, made available through the use of the formation tool 100. To illustrate, Figures 9B and 9C show a first displacement direction (indicated by "X1" in Figures 9B and 9C) and a second direction (indicated by "Y1" in Figures 9B and 9C). The second direction can correspond to a generally vertical direction in which the augment opening 114 can be positioned and / or formed in the bone 115, and thus the augment 162, at a position that is displaced or offset relative to the stem 164, the femoral component 160, and / or the guide 108. In the illustrated example, the asymmetric freedom in the positioning of the augment opening 114, and thus the position of the augment 162, can be provided, at least in part, by a difference in length along the first direction (X1) and a length along the second direction (Y1). Furthermore, such asymmetric freedom in the position of the augment 162 relative to at least the intramedullary canal 112, the guide 108, the stem 164, and / or the femoral component 160 can be provided by using a formation tool 100 having asymmetric guide slots 134, such as the asymmetric guide slots 134c, 134d shown in FIGS. 5A-6B.

[0033] Furthermore, although two displacement directions have been generally described, the asymmetric positional degree of freedom described above in relation to at least Figures 9A-9C may extend in other directions, including between the first direction X1 and the second direction Y1 or combinations of the first direction X1 and the second direction Y1, and along a third axis, such as along the "Z" axis referenced in Figure 4C.

[0034] 10A and 10C show an augment 176 of a tibial implant 172, in which an exemplary tibial implant 172 further includes a tibial tray 174, a tibial augment 176, and a stem 178. In addition, FIG. 10B illustrates how the components of the tibial implant 172, including, for example, the tibial base or tray 174, the tibial augment 176, the stem 178, and / or other tibial components 180, and the integrity of these components and at least the integrity of the formed or shaped augment opening 114 and / or associated bone 115 (FIG. 2), provide for irregular or inconsistent degrees of freedom that may be obtained with respect to the positioning of the formation tool 100 and / or the positioning of the augment 176 in the associated augment opening 114 or bone 115. For example, as shown in FIG. 10B, the degrees of freedom available for forming the augment opening 114 and the resulting relative position of at least the augment 176 and the stem 178 and / or tray stem 180 along a first direction (indicated by "X1" in FIG. 10B) can be greater than the degrees of freedom available along a second adjacent and non-perpendicular direction (indicated by "Z1" in FIG. 10B).

[0035] Although the present invention has been described in connection with what is presently believed to be the most practiced and preferred embodiment, the present invention is not limited to the disclosed embodiment, but rather is intended to encompass various modifications and equivalent arrangements within the spirit and scope of the appended claims, which are to be accorded the broadest interpretation so as to encompass all such modifications and equivalent arrangements as permitted under law. Furthermore, the use of the words preferred, preferred, or preferred in the above description means that the features so described are more desirable, but may not be essential, and embodiments without such features may be considered within the scope of the present invention as defined by the following claims. When terms such as "a," "an," "at least one," and "at least a portion" are used in connection with the claims, it is not intended that the claims be limited to only one item unless specifically recited in the claims. Furthermore, when the terms "at least a portion" and / or "a portion" are used, the item may include a portion and / or the entirety of the item, unless specifically recited otherwise. [Explanation of symbols]

[0036] 100 Shaping Tools 102 Bone Preparation Device 104 Distal end 106 Proximal end 108 Guide 110 Guide axis 111 Longitudinal axis 112 Intramedullary canal 114 Augmented opening 115 Bones 116 Central Augment Axis Platforms 118a and 118b 126 Longitudinal axis 134 Guide slot 138 First Section 140 Second Section 146 Connection parts 150 center line 162 Augment

Claims

1. 1. A forming tool comprising: The forming tool comprises: a guide slot extending through both ends of the formation tool into the formation tool, the guide slot configured to axially receive insertion of a guide configured to be positioned within an intramedullary canal, the guide slot sized to receive linear displacement of the formation tool about the received guide in one or more directions perpendicular to a longitudinal axis of the formation tool; a bone preparation device coupled to an outer wall of the formation tool by a connecting member, the bone preparation device configured to displace bone material; It is equipped with the guide slot has a guide slot axis extending in the same direction as the longitudinal axis of the forming tool; The guide slot has a first axis extending perpendicular to the guide slot axis in a cross section of the guide slot taken in a direction perpendicular to the guide slot axis, and a second axis extending perpendicular to the first axis, the guide slot has a first side and a second side defined by bisecting a cross section taken perpendicular to the guide slot axis about the second axis passing through the guide slot axis; the first side is configured to accommodate linear displacement of the forming tool relative to the received guide along the first axis to a greater distance than would be accommodated by the second side of the guide slot along the first axis; the second side is configured to accommodate linear displacement of the forming tool relative to the received guide along the second axis to a greater distance than would be accommodated by the first side along the second axis; The form tool, wherein the first axis is different from the second axis.

2. 2. The forming tool of claim 1, wherein the guide slot has a cross-sectional shape such that, when cut in a direction perpendicular to the guide slot axis, the shape of one side of the cross-sectional shape extending in the direction along which the first axis extends is different from the shape of the other side of the cross-sectional shape when the second axis is used as a dividing line and the cross-sectional shape of the guide slot is divided by the dividing line.

3. The forming tool according to claim 1, characterized in that the guide slot has a cross-sectional shape that is axisymmetric in a cross section cut in a direction perpendicular to the guide slot axis, with the first axis being the axis of symmetry, in the direction in which the second axis extends.

4. 4. A forming tool as claimed in claim 2 or claim 3, wherein the guide slot axis extends parallel to the longitudinal axis of the forming tool such that it is offset from the longitudinal axis of the forming tool.

5. a proximal end of the outer wall includes a pair of opposing arms configured to receive an impact force from an implantation tool; A form tool according to any preceding claim, wherein the pair of opposing arms extend generally perpendicular to the longitudinal axis of the form tool.

Images