Knee arthroplasty methods and instruments

Abstract

To provide, e.g., a stem provisional assembly that can be configured to be moveable in vivo to position a stem provisional assembly within a bone recess.SOLUTION: According to one example, a provisional system for a knee arthroplasty is disclosed. The system can include any one or combination of a first provisional component 212, a second provisional component 154, a stem provisional assembly 124 and a fastener 214. The first provisional component can be configured to be disposed on a resected bone surface. The second provisional component can be configured to be disposed in a first recess beneath the resected bone surface. The stem provisional assembly can be configured to be disposed in a second recess, and is configured to be engageable in vivo to position the first provisional component on the resected bone surface. The fastener can be configured to couple the first provisional component, the second provisional component and the stem provisional assembly together as an assembly.SELECTED DRAWING: Figure 19

Description

[Technical Field]

[0001] [CROSS-REFERENCE TO RELATED APPLICATIONS] This application claims priority to U.S. Provisional Patent Application No. 62 / 572,210, filed October 13, 2017, the benefit of which is hereby claimed and incorporated herein by reference in its entirety.

[0002] The subject matter of this application relates to orthopaedic surgical instruments, systems, methods and techniques. In particular, this application relates to instruments, systems, methods and techniques that can be used in revision knee arthroplasty. [Background technology]

[0003] Joint arthroplasty procedures and prostheses are commonly utilized to repair and / or replace damaged bones and tissues in the human body. For example, knee arthroplasty can be used to restore natural knee joint function by repairing damaged or diseased articular surfaces of the femur and / or tibia. The knee joint is incised to expose the bones comprising the joint. Cutting guides and other instruments are used to guide the removal of the articular surfaces to be replaced. A prosthesis is used to recreate the articular surface. An artificial knee joint can include a femoral component implanted at the distal end of the femur, which articulates with a tibial bearing component and a tibial component implanted at the proximal end of the tibia to recreate healthy natural knee function. Various types of joint arthroplasty are known, including total knee replacement, in which all of the articular compartments of the joint are repaired with artificial components, and revision knee arthroplasty, in which a physician removes a previously implanted artificial knee joint and replaces it with a new artificial knee joint. Summary of the Invention

[0004] The present disclosure generally relates to surgical instruments, systems, methods, and techniques for knee arthroplasty, such as revision knee arthroplasty. The inventors have recognized that, among other things, provisional components, instrument designs, systems, and processes can simplify knee surgery, reduce its cost, and / or improve its efficiency. For example, the present application discloses provisional systems that can be coupled together and positioned in vivo to better match the patient's anatomy. In particular, the present application discloses stem provisional assemblies that can be configured to be movable in vivo to position the stem provisional assembly within a bony recess.

[0005] To reduce the cost and number of components, the stem temporary assembly can comprise a system that can include a plurality of adapters and a plurality of stem extensions. Each of the plurality of adapters can have a longitudinal axis extending between a proximal end and a distal end. The plurality of adapters includes at least a first adapter having a longitudinal axis with no offset and at least a second adapter having a longitudinal axis with a predetermined amount of offset. Each of the plurality of stem extensions can be configured to interchangeably mate with the plurality of adapters. Each of the plurality of stem extensions can have a different longitudinal dimension between the proximal end and the distal end.

[0006] In another aspect that saves time, reduces costs, and simplifies procedures, a system of provisional components that can be assembled in vivo and then removed is disclosed. In particular, after assembly in vivo, the assembly can be removed from the patient's body while maintaining the position of each component relative to one another. This allows for easier and more timely production of a permanent implant based on the provisional assembly, since the positions of the individual provisional components do not need to be documented or detailed. The entire provisional assembly, with each part in the desired position relative to one another, can be maintained as a simple reference. These and other aspects of the present application will be discussed in more detail hereinafter. Those skilled in the art will recognize that this application includes various other inventive concepts that simplify, reduce costs, and improve efficiency in knee surgery.

[0007] The following non-limiting examples are presented to further illustrate the devices, systems and methods disclosed herein.

[0008] In Example 1, a provisional system for knee arthroplasty is disclosed. The system can include a first provisional component having a proximal surface and a distal surface opposite the proximal surface, one of the distal and proximal surfaces configured to be positioned on a resected surface of a bone. The system can include a second provisional component configured to be positioned within a first recess below the resected surface of the bone. The second provisional component is configured to mimic the shape of at least one of a sleeve component, a cone component, or a keel component of an implant. The system can include a stem provisional assembly configured to be positioned within the second recess, the stem provisional assembly configured to be engageable in vivo to position the first provisional component on the resected surface of the bone. The system can include a fastener configured to couple the first provisional component, the second provisional component, and the stem provisional assembly together as an assembly, the fastener including a passageway that allows access to the stem provisional assembly from adjacent portions of the first provisional component.

[0009] In Example 2, the system of Example 1 can optionally further include a handle configured to temporarily engage the second provisional component with the stem provisional assembly, such that when temporarily engaged with the handle, the second provisional component and the stem provisional assembly are insertable into the first and second recesses, respectively, of the bone.

[0010] In Example 3, the system of any one of Examples 1-2 or a combination thereof can optionally further include a driver or multiple drivers configured for at least one of engaging the fastener to thread the fastener into the threaded recess of the stem provisional assembly and passing through the passage of the fastener to engage the stem provisional assembly, wherein engagement between the driver and the stem provisional assembly rotates the stem provisional assembly in vivo to position the first provisional component on the resection surface.

[0011] In Example 4, the system of any one of Examples 1-3 or any combination thereof, wherein the first temporary component can optionally include a first taper and a second taper, the second temporary component includes a third taper and a fourth taper, and the stem temporary assembly includes a fifth taper, wherein the first taper is configured to engage with the third taper, the second taper is configured to engage with the fifth taper, and the fourth taper is configured to engage with the fifth taper when a fastener couples the first temporary component, the second temporary component, and the stem temporary assembly together as an assembly.

[0012] In Example 5, the system of Example 4 can be such that the first taper and the fifth taper optionally comprise outer tapers, and the second taper, the third taper, and the fourth taper optionally comprise inner tapers.

[0013] In Example 6, the system of any one of Examples 1-5 or any combination thereof, wherein the fastener, first temporary component, second temporary component, and stem temporary assembly are optionally removable from the bone together as an assembly while maintaining the position of each component relative to one another.

[0014] In Example 7, the system of any one of Examples 1 to 6 or any combination thereof may be a system in which the stem provisional assembly optionally includes a plurality of adapters, each having a longitudinal axis extending between a proximal end and a distal end, the plurality of adapters including at least a first adapter having a longitudinal axis with no offset and at least a second adapter having a longitudinal axis with a predetermined amount of offset, and a plurality of stem extensions, each configured to be interchangeably coupled to the plurality of adapters, the plurality of stem extensions each having a different longitudinal dimension between the proximal end and the distal end.

[0015] In Example 8, the system of Example 7 can include at least a second adapter, optionally two adapters, one adapter having a first amount of offset and another adapter having a second amount of offset different from the first amount of offset.

[0016] In Example 9, the system of any one of Examples 1 to 6 or any combination thereof, optionally includes a single subsystem in which the stem sub-assembly includes a plurality of monolith integrated assemblies, each of which includes an adapter portion and a stem extension portion.

[0017] In Example 10, the system of any one of Examples 1-9 or any combination thereof, optionally, the first provisional component can include a femoral component having an elongated slot configured to receive a pin therein, the elongated slot configured to allow proximal-distal movement of the femoral component relative to the pin.

[0018] In Example 11, the system of any one of Examples 1-10 or any combination thereof, the second temporary component can optionally include a broach configured to remove bone to create the first recess.

[0019] In Example 12, a tibial or femoral provisional system for total knee arthroplasty is disclosed. The system can include a first provisional component having a proximal surface and a distal surface opposite the proximal surface, where one of the proximal or distal surfaces is configured to be positioned on a resected surface of a bone, including the tibia or femur. The system can include a second provisional component configured to be positioned within a first recess below the resected surface, the second provisional component being provisional to mimic the shape of at least one of a sleeve component, a cone component, or a keel component of an implant. The system can include a stem provisional assembly configured to be positioned within the second recess of the tibia or femur, where the stem provisional assembly is configured to be engageable in vivo to reposition the first provisional component on the resected surface. The system can include a fastener configured to couple the first provisional component, the second provisional component, and the stem provisional assembly together as a single assembly.

[0020] In Example 13, the system of Example 12 can optionally include a passageway that allows access for a fastener to engage the stem temporary assembly.

[0021] In Example 14, the system of Example 12 can optionally further comprise a driver or multiple drivers configured to at least one of engage a fastener to thread the fastener into the threaded recess of the stem provisional assembly and penetrate the fastener passage to engage the stem provisional assembly, wherein engagement between the driver and the stem provisional assembly rotates the stem provisional assembly in vivo.

[0022] In Example 15, the system of any one of Examples 12-14 or any combination thereof, wherein the fastener, the first provisional component, the second provisional component, and the stem provisional assembly are optionally removable from the tibia together as an assembly while maintaining their respective positions relative to one another.

[0023] In Example 16, the system of any one of Examples 12 to 15 or any combination thereof can include a system in which the stem provisional assembly optionally includes a plurality of adapters each having a longitudinal axis extending between a proximal end and a distal end, the plurality of adapters including at least a first adapter having a longitudinal axis with no offset and at least a second adapter having a longitudinal axis with a predetermined amount of offset, and a plurality of stem extensions each configured to interchangeably couple with the plurality of adapters, the plurality of stem extensions each having a different longitudinal dimension between the proximal end and the distal end.

[0024] In Example 17, the system of any one of Examples 12 to 15 or any combination thereof, the stem sub-assembly can optionally be a subsystem comprising a plurality of monolith integrated assemblies, each of the plurality of monolith integrated assemblies including an adapter portion and a stem extension portion.

[0025] In Example 18, a method for revision knee arthroplasty can optionally include shaping a patient's bone to create one or more recesses therein, selecting a stem provisional assembly, positioning the stem provisional assembly within the one or more recesses, and assembling the stem provisional assembly in vivo with both a first provisional component configured to mimic the shape of one of a tibial tray implant or a femoral implant and a second provisional component configured to mimic the shape of at least one of a sleeve component, a cone component, or a keel component of the implant.

[0026] In Example 19, the method of Example 18 can optionally further include temporarily coupling the second temporary component and the stem temporary assembly together with a handle configured for insertion over the post extension, and inserting the stem temporary assembly and the second temporary component together into the one or more recesses.

[0027] In Example 20, the method of Examples 18 or 19 or a combination thereof can further optionally include identifying the axis of the bone and determining whether an offset configuration of the stem provisional assembly is desirable.

[0028] In Example 21, the method of any one of Examples 18 to 20 or any combination thereof, wherein selecting the stem temporary assembly optionally includes selecting a monolith temporary stem having an adapter portion and a stem extension portion, or selecting an adapter from a plurality of adapters each having a longitudinal axis extending between a proximal end and a distal end, the plurality of adapters including at least a first adapter having a longitudinal axis with at least no offset and a second adapter having a longitudinal axis with a predetermined amount of offset, and selecting a stem extension from a plurality of stem extensions each configured to couple with the plurality of adapters, the plurality of stem extensions each having a different longitudinal dimension between the proximal end and the distal end.

[0029] In Example 22, the method of any one of Examples 18 to 21 or any combination thereof, wherein the step of in vivo assembling the stem provisional assembly with both the first provisional component configured to mimic the shape of one of the tibial tray implant or the femoral implant and the second provisional component configured to mimic the shape of at least one of the sleeve component or the keel component of the implant can optionally include one or both of engaging a fastener to thread the fastener into the threaded recess of the stem provisional assembly and passing a tool through the fastener passage to engage the stem provisional assembly distal to the threaded recess.

[0030] In Example 23, the method of any one of Examples 18-22 or any combination thereof can optionally further include engaging the stem provisional assembly in vivo to position the first provisional component at a desired location on the resected surface of the bone.

[0031] In Example 24, the method of any one of Examples 18-23 or any combination thereof can further include removing at least the first temporary component, the second temporary component, and the stem temporary assembly together from the bone and the one or more recesses while maintaining their respective positions relative to one another.

[0032] In Example 25, the method of Example 24 optionally further includes configuring an implant assembly based on the positions of the first provisional component, the second provisional component, and the stem provisional assembly.

[0033] In Example 26, the system of any one of Examples 1-17 or any combination thereof can further optionally include a multi-purpose handle configured to couple with one or more of the second temporary component and the offset broach, the multi-purpose handle including a slap hammer having a cannulated shaft and configured to be movable along and securable to the shaft of the handle.

[0034] In Example 27, the system of Example 26 is such that the offset broach optionally has a cutting surface only along its first side, a second surface opposite the first surface configured to receive and interface with the reamer, and the offset broach configured to offset the first recess relative to the second recess.

[0035] In Example 28, the method of any one of Examples 18-25 or any combination thereof may further optionally include coupling a multipurpose handle to one or more of the second temporary component and the offset broach, and extracting the offset broach from the bone using a slap hammer movement of the multipurpose handle.

[0036] In Example 29, the method of Example 28 is further characterized in that the offset broach has a cutting surface only along a first side thereof, a second side opposite the first side configured to receive and interface with the reamer, and the offset broach configured to offset a first portion of the one or more recesses relative to a second portion of the one or more recesses.

[0037] In Example 30, the system of any one or any combination of Examples 1-17 and 26-27 can optionally further comprise a drill guide configured to be attachable to the stem provisional assembly and configured to pre-drill bone prior to broaching for the sleeve or cone component.

[0038] In Example 31, the method of any one of Examples 18-25 and 28-29 or any combination thereof can optionally include coupling a drill guide to the stem provisional assembly to create one or more recesses therein, the drill guide having a plurality of apertures configured to receive and guide a drill into the bone; and broaching the bone.

[0039] In Example 32, the system of any one of Examples 1-17 and 26-27 and 30, or any combination thereof, can optionally further include an angled reamer having a distal nose portion and a cutting portion with a back angle taper having a tapered diameter measured distally to proximally along the longitudinal axis of the angled reamer.

[0040] In Example 33, the method of any one of Examples 18-25, 28-29, and 31, or any combination thereof, optionally, shaping the patient's bone to create one or more recesses therein can include reaming the bone with an angled reamer having a distal nose portion and a cutting portion with a back angle taper having a tapered diameter measured distally to proximally along a longitudinal axis of the angled reamer.

[0041] In Example 34, the system of any one of Examples 1-17, 26-27, 30, and 32, or any combination thereof, can optionally further include a tibial gut guide assembly configured to guide resections to form the resection surface, the tibial cut guide assembly having a boom arm and a body coupled to the boom arm by a collar, the collar including an opening configured to allow removal of the boom arm from the collar without changing the position of the body relative to the bone.

[0042] The method of any one of Examples 18-25, 28-29, 31, and 33, or any combination thereof, optionally further includes resecting bone with a tibial cut guide assembly to form a resection surface, the resection including positioning a body of the tibial cut guide assembly adjacent a proximal portion of the tibia with a boom arm, pinning the body to the proximal portion, and removing the boom arm without removing the body from its pinned position to the proximal portion.

[0043] In Example 36, the system of any one of Examples 1-17, 26-27, 30, 32, and 34, or any combination thereof, can further optionally include a stem implant configured with one or more slots along a distal portion to allow the stem implant to bend in any direction.

[0044] In Example 37, the assembly can optionally include a fastener having a threaded portion and a head portion, and a component having a bore, the bore optionally including a corresponding threaded portion configured to mate with the threaded portion of the fastener, a pocket portion in the bore adjacent the corresponding threaded portion, the pocket portion configured to receive the fastener when the threaded portion of the fastener is unscrewed from the corresponding threaded portion, and a restriction disposed adjacent the pocket portion, the restriction portion configured to have a diameter substantially equal to or smaller than the head portion to retain the fastener in the pocket when the threaded portion of the fastener is unscrewed from the corresponding threaded portion.

[0045] In Example 38, the assembly of Example 37 can optionally have a pocket portion with a diameter greater than the diameter of the head portion.

[0046] In Example 39, the assembly of Examples 37 or 38 or a combination thereof can optionally include one or more of the restriction and the head portion of the fastener having a chamfer configured to act as a bevel to facilitate insertion of the head portion past the restriction.

[0047] In Example 40, the apparatus, system, and method of any one of Examples 1-39 or any combination thereof can be configured so that, optionally, all of the elements or options mentioned are usable or selectable.

[0048] These and other embodiments and features of the devices and systems of the present invention are described in part in the detailed description below. This summary is intended to present non-limiting examples of the present subject matter and is not intended to present an exclusive or exhaustive description. The description below is included to provide further information about the devices and methods of the present invention.

[0049] The drawings are not necessarily to scale, and like reference numbers refer to like components in the drawings. Like reference numbers with different suffix letters may represent different instances of like components. The drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present application. [Brief explanation of the drawings]

[0050] [Figure 1] 1 is a cross-sectional view of a reamer inserted into a bone, such as a tibia, according to one embodiment of the present application. [Figure 2] FIG. 1 is a perspective view of a reamer together with a tibial sizer and coupler according to one embodiment of the present application. [Figure 3] FIG. 3 is an elevational view of the reamer and tibial sizer shown in FIG. 2, but with an offset coupler assembly used to position the tibial sizer relative to the reamer, according to one embodiment of the present application. [Figure 3A] FIG. 4 is a perspective view of the reamer, tibial sizer, and offset coupler assembly of FIG. 3 according to one embodiment of the present application. [Figure 4] FIG. 1 is a perspective view of a multi-purpose handle according to one embodiment of the present application. [Figure 5] FIG. 5 is a perspective view of the multi-purpose handle of FIG. 4 coupled with an offset broach, according to one embodiment of the present disclosure. [Figure 5A] 1 shows a multipurpose handle and offset broach being placed longitudinally along the shaft of the reamer into the tibia to remove bone from the tibia to create a recess according to one embodiment of the present application. [Figure 6A]1 shows a multipurpose handle and offset broach being placed longitudinally along the shaft of the reamer into the tibia to remove bone from the tibia to create a recess according to one embodiment of the present application. [Figure 6B] 1 shows a multipurpose handle and offset broach being placed longitudinally along the shaft of the reamer into the tibia to remove bone from the tibia to create a recess according to one embodiment of the present application. [Figure 7A] FIG. 1 is a perspective view of an angled reamer having a tapered cutting section for removing bone from a tibia to create a recess, according to one embodiment of the present application. [Figure 7B] 7B is a cross-sectional view of the angled reamer of FIG. 7A being inserted into the bone to remove bone from the tibia to create a recess according to one embodiment of the present application. [Figure 7C] FIG. 7C is a plan view of the bevel reamer of FIGS. 7A and 7B. [Figure 8A] 1 illustrates a cannulated reamer for removing bone from the tibia to create a recess, the cannulated reamer being insertable over a post coupled to a first stem provisional assembly, according to one embodiment of the present application. [Figure 8B] 1 illustrates a cannulated reamer for removing bone from the tibia to create a recess, the cannulated reamer being insertable over a post coupled to a first stem provisional assembly, according to one embodiment of the present application. [Figure 8C] 1 illustrates a cannulated reamer for removing bone from the tibia to create a recess, the cannulated reamer being insertable over a post coupled to a first stem provisional assembly, according to one embodiment of the present application. [Figure 9A] 1 illustrates a drill guide and drill that can be used to remove bone from the tibia to create a recess, according to one embodiment of the present application. [Figure 9B] 1 illustrates a drill guide and drill that can be used to remove bone from the tibia to create a recess, according to one embodiment of the present application. [Figure 10A]5A-5C illustrate a second temporary component configured to mimic the multi-purpose handle and cone of FIGS. 5-6B, according to one embodiment of the present application. [Figure 10B] 5A-5C illustrate a second temporary component configured to mimic the multi-purpose handle and cone of FIGS. 5-6B, according to one embodiment of the present application. [Figure 10C] 5A-5C illustrate a second temporary component configured to mimic the multi-purpose handle and cone of FIGS. 5-6B, according to one embodiment of the present application. [Figure 10D] 5A-5C illustrate a second temporary component configured to mimic the multi-purpose handle and cone of FIGS. 5-6B, according to one embodiment of the present application. [Figure 10E] 5A-5C illustrate a second temporary component configured to mimic the multi-purpose handle and cone of FIGS. 5-6B, according to one embodiment of the present application. [Figure 11A] 10A-10E engaging an assembly of a second temporary component, a post, and a first stem temporary assembly, according to one embodiment of the present application. FIG. [Figure 11B] 10A-10E engaging an assembly of a second temporary component, a post, and a first stem temporary assembly, according to one embodiment of the present application. FIG. [Figure 11C] FIG. 10 is a perspective view illustrating a handle used to insert an assembly of a second provisional component, a post, and a first stem provisional assembly into one or more recesses of the proximal tibia according to one embodiment of the present application. [Figure 11D] FIG. 10 is a perspective view illustrating a handle used to insert an assembly of a second provisional component, a post, and a first stem provisional assembly into one or more recesses of the proximal tibia according to one embodiment of the present application. [Figure 11E] FIG. 10 is a perspective view illustrating a handle used to insert an assembly of a second provisional component, a post, and a first stem provisional assembly into one or more recesses of the proximal tibia according to one embodiment of the present application. [Figure 12] 10 illustrates another assembly of a second temporary component, a post, and a second stem temporary assembly according to one embodiment of the present application. [Figure 13]10 illustrates a cutting tool resecting an end portion of a bone using a first surface of a second temporary component as a reference for establishing a resection plane, according to one embodiment of the present application. [Figure 14A] 14 is a perspective view of a cutting guide for guiding the cutting tool of FIG. 13 to remove an end portion of a bone, according to an embodiment of the present application. [Figure 14B] 14 is a perspective view of a cutting guide for guiding the cutting tool of FIG. 13 to remove an end portion of a bone, according to an embodiment of the present application. [Figure 14C] 14 is a perspective view of a cutting guide for guiding the cutting tool of FIG. 13 to remove an end portion of a bone, according to an embodiment of the present application. [Figure 15] FIG. 1 is a perspective view of a proximal end portion of a tibia having a resected surface and a recess, a second provisional component positioned within the recess and the tibial tray provisional component, and a fastener configured to couple with the second provisional component, according to an embodiment of the present application. [Figure 16] 1 is a perspective view of a driver tool according to one embodiment of the present application. [Figure 17] 16 illustrates the driver tool of FIG. 16 being inserted into and engaged with the fastener of FIG. 15 to fasten the fastener to couple the second provisional component to the tibial tray provisional component, thereby forming part of a provisional tibial assembly, according to one embodiment of the present application. [Figure 18] 18 illustrates a portion of the tibial temporary assembly of FIG. 17 when the tibial tray provisional component and the second provisional component are coupled with fasteners, according to one embodiment of the present application. [Figure 19] FIG. 19 is a cross-sectional view of a complete tibial temporary assembly including a portion of the tibial temporary assembly shown in FIGS. 17-18, the complete tibial temporary assembly including a tibial tray temporary component, a fastener and second temporary component, and a stem temporary assembly, according to one embodiment of the present application. [Figure 20] 1 is a perspective view of a complete tibial false bone assembly removed from the tibia and placed in a workspace to be used to construct a first tibial implant assembly, according to one embodiment of the present application. FIG. [Figure 21]FIG. 10 is a perspective view of another temporary tibial assembly having a second temporary component configured to mimic a keel removed from the tibia and placed in a working space used to construct a second tibial implant assembly, according to one embodiment of the present application. [Figure 22A] 1 illustrates the process of positioning the stem provisional assembly without showing the driver tool, the tibial tray provisional component, and the second provisional component to further illustrate the engagement between the driver and the stem provisional assembly according to one embodiment of the present application. [Figure 22B] The process of positioning the stem provisional assembly is shown without showing the driver tool, the tibial tray provisional component, and the second provisional component to further illustrate the engagement between the driver and the stem provisional assembly according to one embodiment of the present application. [Figure 23A] 22A and 22B are plan views illustrating that the positioning process can be performed in vivo and that the positioning of the stem provisional assembly can alter the positioning of the tibial tray provisional component on the resected proximal surface of the tibia, according to one embodiment of the present application. [Figure 23B] 22A and 22B are plan views illustrating that the positioning process can be performed in vivo and that the positioning of the stem provisional assembly can alter the positioning of the tibial tray provisional component on the resected proximal surface of the tibia, according to one embodiment of the present application. [Figure 24] 1 illustrates a system that can be utilized to configure various configurations of stem temporary assemblies as desired, according to one embodiment of the present application. [Figure 25] FIG. 1 is a perspective view of a femur with a reamer inserted therein and an offset coupler assembly used to position a cutting guide at the distal end of the femur, according to one embodiment of the present application. [Figure 26] 1 illustrates a femoral provisional assembly including a femoral provisional component, a second provisional component, and a stem provisional assembly according to one embodiment of the present application. [Figure 26A] 1 illustrates a femoral provisional assembly including a femoral provisional component, a second provisional component, and a stem provisional assembly according to one embodiment of the present application. [Figure 27]26 and 26A show a femoral provisional component including an elongated slot that allows for desired proximal-distal adjustment of the position of the femoral provisional component relative to the distal portion of the femur, according to one embodiment of the present application. [Figure 28] 26 and 26A show a femoral provisional component including an elongated slot that allows for desired proximal-distal adjustment of the position of the femoral provisional component relative to the distal portion of the femur, according to one embodiment of the present application. [Figure 29] 10 illustrates another configuration of a stem extension that can be used in a stem temporary assembly according to an embodiment of the present application. [Figure 30] 10 illustrates another configuration of a stem extension that can be used in a stem temporary assembly according to an embodiment of the present application. [Figure 31] 10 illustrates another configuration of a stem extension that can be used in a stem temporary assembly according to an embodiment of the present application. [Figure 32] 10 illustrates another configuration of a stem extension that can be used in a stem temporary assembly according to an embodiment of the present application. [Figure 33] 1 illustrates a revision knee arthroplasty method according to one embodiment of the present application. [Figure 34] 34 illustrates a method that can be used as part of the method of FIG. 33 according to one embodiment of the present application. [Figure 35A] FIG. 1 is a cross-sectional view of a component and fastener assembly having a pocket and a restriction for retaining the fastener so that it cannot move from the component once received in the pocket, according to one embodiment of the present application. [Figure 35B] FIG. 1 is a cross-sectional view of a component and fastener assembly having a pocket and a restriction for retaining the fastener so that it cannot move from the component once received in the pocket, according to one embodiment of the present application. [Figure 36A] FIG. 35C is a cross-sectional view of another assembly configured similarly to FIGS. 35A and 35B but including a passageway, according to one embodiment of the present application. [Figure 36B] FIG. 35C is a cross-sectional view of another assembly configured similarly to FIGS. 35A and 35B but including a passageway, according to one embodiment of the present application. [Figure 37A]17 illustrates a driver tool that can be used in place of the driver tool of FIG. 16 according to one embodiment of the present application. [Figure 37B] 17 illustrates a driver tool that can be used in place of the driver tool of FIG. 16 according to one embodiment of the present application. [Figure 38] 25 illustrates a system of monolith stem pre-assembly that can be used in place of the system of FIG. 24, according to one embodiment of the present application. DETAILED DESCRIPTION OF THE INVENTION

[0051] TECHNICAL FIELD This application relates to provisional prostheses, tools, systems and methods.

[0052] As described above, the provisional prostheses, instruments, systems, and methods can simplify, reduce the cost, and / or improve the efficiency of knee surgery. All of the instruments, components, systems, methods, and techniques described herein can be used on the femur and tibia and are equally applicable.

[0053] As used herein, "proximal" and "distal" shall be interpreted generally anatomically. "Proximal" shall mean generally a direction toward the patient's torso, and "distal" shall mean the opposite of proximal, i.e., a direction away from the patient's torso. The use of "proximal" and "distal" shall be interpreted as a patient standing with the knee extended. "Proximal" and "distal" are intended to be distinguished from "anterior" and "posterior." As used herein, "anterior" and "posterior" shall be interpreted generally anatomically. Thus, "posterior" means the posterior of the patient, e.g., behind the knee. Similarly, "anterior" means the anterior of the patient, e.g., in front of the knee. Thus, "posterior" means the opposite of "anterior." "Medial" and "lateral" shall be interpreted generally anatomically. Thus, "medial" means the opposite of "lateral."

[0054] FIG. 1 illustrates a cross-sectional view of a tibia 10 and a reamer 14. Only the proximal portion 12 of the tibia 10 is shown in FIG. 1. The reamer 14 is inserted into the tibia 10 and can be configured with fluted grooves or sharp edges to remove bone and create a recess 16 therein. The recess 16 can, in some cases, be formed at least in part by the patient's existing anatomy, such as the intramedullary canal. In some cases, it may be desirable to insert the reamer to follow the intramedullary canal to create the recess 16 and / or align the provisional and implant components with the mechanical and anatomical axes of the tibia 10. The tibia 10 may be the target of a revision knee arthroplasty. In this case, prior to the reaming process illustrated in FIG. 1 , the tibia 10 was implanted with a tibial implant component, which will be removed as part of the revision knee arthroplasty. As discussed and illustrated further below, the proximal portion 12 may have diseased or other undesired bone that needs to be removed as part of the revision knee arthroplasty before a new implant is placed in the proximal portion 12.

[0055] FIG. 2 is a perspective view of the reamer 14, tibial sizer 18, and coupler 20. The coupler 20 can be configured to engage the tibial sizer 18 and receive the reamer 14. In this manner, the tibial sizer 18 can be coupled to the reamer 14 via the coupler 20. The embodiment of FIG. 2 illustrates that the coupler 20 can be configured to provide no offset to the tibial sizer 18 relative to the reamer 14. The reamer 14 can position the tibial sizer 18 on the proximal surface 22 of the tibia 10 via the coupler 20. An appropriately sized tibial sizer 18 can be selected to achieve the desired amount of coverage of the proximal surface 22 with little or no overhang. An assembly in which the tibial sizer 18 does not have an offset can be desirable if the tibial sizer 18 is properly positioned on the proximal surface 22 and substantially aligned with the mechanical and anatomical axis of the tibia 10 as indicated by the reamer 14. Once the proper size and position have been determined, the desired markings on the proximal tibia can be made and the tibial sizer 18 and coupler 20 can be removed, leaving the reamer 14 in the tibia 10.

[0056] 3 and 3A show another assembly of the reamer 14, tibial sizer 18 and offset coupler 24. The offset coupler 24 can include a distal portion 26 and a proximal portion 28.

[0057] The distal portion 26 can be engaged with the tibial sizer 18 similar to the coupler 20 of FIG. 2 . However, the proximal portion 28 can be configured as a dial so that it is movable relative to the distal portion 26. Because the tibial sizer 18 is not fixed relative to the tibia 10, and the position of the reamer 14 is fixed relative to the tibia 10, movement of the proximal portion 28 relative to the distal portion 26 can move the position of the tibial sizer 18 on the proximal surface 22 of the tibia 10. The proximal portion 28 can be rotated relative to the distal portion 26 until the desired position of the tibial sizer 18 is achieved. Indicators 29A, 29B can be provided on the distal portion 26 and the proximal portion 28, respectively. The indicators 29A, 29B can be used to indicate the position of the tibial sizer 18 relative to the reamer 14.

[0058] As can be seen from the embodiment of FIG. 3 , the proximal portion 28 can have a plurality of through-holes 30A, 30B configured to receive the reamer 14. The plurality of through-holes 30A, 30B can include a first through-hole 30A and a second through-hole 30B. In particular, the plurality of through-holes 30A, 30B can have parallel longitudinal axes and can be in fluid communication with one another. The through-holes 30A and 30B can be configured to provide a variable offset of the offset coupler 24 and tibial sizer 18 relative to the reamer 14. For example, the first through-hole 30A can provide a 3 mm offset of the offset coupler 24 and tibial sizer 18 relative to the reamer 14, while the second through-hole 30B can provide a 6 mm offset of the offset coupler 24 and tibial sizer 18 relative to the reamer 14.

[0059] 4-6B illustrate a multi-purpose handle 50. The handle 50 can also be used with the instruments, systems, and methods of Figures 10A-11D. As shown in Figure 4, the tool 50 can include a distal tip 52, a pin 54, a collar 56, a shaft 58, a proximal end portion 60, and a slap hammer 62.

[0060] The handle 50 extends along a longitudinal axis L from a distal tip 52 to a proximal end portion 60. The distal tip 52 can be connected to a shaft 58. The shaft 58 can be connected to the proximal end portion 60. In fact, the shaft 58 can form the proximal end portion 60. The pin 54 can be disposed along the shaft 58 and connected to a collar 56. The collar 56 can be disposed around the shaft 58 and can be movable proximally-distally (along the longitudinal axis L) relative to the shaft. A slap hammer 62 can be movably connected to the proximal end portion 60. The slap hammer 62 can be configured to be grasped by a user and movable proximally-distally (along the longitudinal axis L and the shaft 58).

[0061] Distal tip 52 can be configured with one or more features 64 (FIG. 4), such as protrusions, configured to engage various other instruments, such as offset broach 66 of FIG. 5. Pin 54 can be movable (extendable and retractable) generally along longitudinal axis L of tool 50. When in the extended position, pin 54 can engage an instrument attached to distal tip 52, such as offset broach 66 of FIG. 5. Pin 54 can be biased to the extended position shown in FIG. 4 by a spring (not shown in FIG. 4, but shown in FIGS. 10A-10D and 11B) or other means. Collar 56 can be coupled to pin 54 and can act as a mechanism for retracting pin 54, if desired.

[0062] 5 shows an offset broach 66 attached at its proximal portion 67 to the distal tip 52. The proximal portion 67 of the offset broach 66 can be engaged by a pin 54 to lock the offset broach 66 in position. The offset broach 66 includes a distal portion 68 configured along only one side 70 thereof as a cutting surface 69. This cutting surface 69 can be tapered with teeth or other types of cutting edges and / or faces.

[0063] As shown in FIG. 5A , the offset broach 66 and handle 50 may be cannulated to receive the reamer 14 therein. In particular, the handle 50 may be cannulated along the longitudinal axis L ( FIG. 4 ) so that at least a portion of the distal tip 52, shaft 58, and / or proximal end portion 60 ( FIG. 4 ) is cannulated. The offset broach 66 may be similarly cannulated between the distal portion 68 and the proximal portion 67. As shown in FIG. 5A , such a cannulated configuration allows the handle 60 and offset broach 66 to be inserted over the reamer 14 from proximal to distal. Once positioned to receive the reamer 14, the offset broach 66 distalizes and contacts the proximal end 12 of the tibia 10 in a controlled motion to remove bone. This allows for the creation of a recess, such as recess 72 in FIG. 5A .

[0064] 6A and 6B are cross-sectional views of the handle 50, offset broach 66, and reamer 14. The reamer 14 is received within the cannulated handle 50 and offset broach 66. FIG. 6B illustrates movement of the slap hammer 62 along the shaft 58 and proximal end portion 60 from the position shown in FIG. 6A. Movement of the slap hammer 62 can be generally controlled proximal-distal movement along a longitudinal axis L (FIG. 4), which can be substantially aligned with the longitudinal axis of the reamer 14. The slap hammer 62 can be configured to impact an enlarged surface 74 of the shaft 58 proximal to the collar 56, as shown in FIG. 6B. This impact action imparts a proximal-distal force to the offset broach 66 through the distal tip 52 along the shaft 58. This force can cause the cutting surface 69 of the offset broach 66 to contact bone, creating a recess 72. Additionally or alternatively, the slap hammer 62 can be configured to be used to extract the offset broach 66 from bone. In some embodiments, the offset broach 66 can be driven into the bone via the handle 50 using a tool to strike the proximal end portion 60 rather than using a drive via the slap hammer 62. In some embodiments, the slap hammer 62 can be configured to lock to the proximal edge portion 60 or to the enlarged surface 74 to prevent the slap hammer 62 from moving along the proximal end portion 60 and shaft 58. The slap hammer 62 can be released when movement is desired, as described above.

[0065] As described above, because the slap hammer 62 is coupled to the shaft 58 and proximal end portion 60, movement of the slap hammer 62 and the resulting force are along the longitudinal axis L of the handle 50. The handle 50 and offset broach 66 can be cannulated to receive the reamer 14, facilitating alignment between the longitudinal axis L of the handle 50 and the longitudinal axis of the reamer 14. Using the reamer 14 as a guide, the impact force from the slap hammer 62 can be directed in a desired direction (e.g., proximal-distal) to create the recess 72. Off-center impact forces tangential to the longitudinal axis direction can be avoided or minimized, thereby protecting the bone preparation.

[0066] 7A and 7B illustrate an angled reamer 100 that can be used in addition to or instead of the offset broach 66 (FIGS. 5-6B). FIG. 7A illustrates an angled reamer 100 that can be used to remove bone from the proximal portion 12 of the tibia 10 to create a recess 72. The angled reamer 100 can have a back angle tapered portion to minimize the risk of over-reaming the bone. FIG. 7B illustrates a cross-sectional view of the angled reamer 100 in the tibia 10. As shown in FIGS. 7B and 7C, the angled reamer 100 can include a distal nose portion 102, a cutting portion 104, and a proximal shaft portion 106. The cutting portion 104 can include a first tapered section 108 and a second tapered section 110.

[0067] The distal nose portion 102 can extend longitudinally to a cutting portion 104. The distal nose portion 102 can be configured to reference a recess 16 in the tibia 10. The recess 16 can be the intramedullary canal of the tibia 10 and / or can be a recess formed by the reamer 14. The distal nose portion 102 can include a rounded, blunt tip 114. The longitudinal length of the distal nose portion 102 can vary depending on the embodiment.

[0068] The cutting portion 104 can have an enlarged diameter relative to the distal nose portion 102 and the proximal shaft portion 106. The first tapered section 108 can be disposed distal to the second tapered section 110 and can connect to the distal nose portion 102. The nose portion 104 can have a length of about 15 mm to about 70 mm, measured from the rounded blunt tip 114 to the beginning of the first tapered section 108. The rounded blunt tip 114 can have a diameter of about 6 mm to about 16 mm and a radius of 5 mm, depending on various embodiments.

[0069] The first tapered section 108 can be a leading portion during surgery, and the second tapered section 110 can be a trailing portion. As shown in FIG. 7C, the first tapered section 108 can have a first taper angle α (also referred to as a leading angle) of about 10 degrees to 40 degrees, measured from the plane of the tapered section 108 to the longitudinal axis A. The length of the first tapered section 108 along the longitudinal axis A can be about 11 mm to about 24 mm. The second tapered section 110 can have an angle of about 4 degrees to about 16 degrees, measured from the plane of the tapered section 108 to the longitudinal axis A. The length of the second tapered section 110 along the longitudinal axis A can be about 20 mm to about 60 mm.

[0070] The first taper angle α can be different from the second taper angle β of the second tapered section 110, measured from the longitudinal axis. The second taper angle β can be in a reverse direction relative to the first taper angle α. In other words, the second tapered section 110 can have a back taper relative to the first tapered section 108. In some embodiments, the longitudinal length of the first tapered section 108 is different from the length of the second tapered section 110.

[0071] In another embodiment, the angled reamer 100 can be configured with only the second tapered section 110, without the first tapered section 108. The second tapered section 110 can be disposed proximal to the first tapered section 108 and can connect to the proximal shaft portion 106. As shown in FIGS. 7B and 7C, the second tapered section 110 can be separated from the first tapered section 108 by a region 109 in some embodiments. The region 109 can include a region having the largest cross-sectional diameter of the angled reamer 100 and can be substantially flat (i.e., with a surface parallel to the longitudinal axis A in FIG. 7C). This region 109 can, in some embodiments, include a sharp transition (e.g., a ridgeline) between the first tapered section 108 and the second tapered section 110. In embodiments in which the region 109 is flat, the region 109 can alternatively have a length of several millimeters relative to the longitudinal axis A (FIG. 7C). Region 109 can have a diameter of about 16 mm to about 60 mm.

[0072] The second tapered section 110 can have a decreasing diameter measured in a distal-to-proximal direction along the longitudinal axis A (FIG. 7C) from the region 109 to the proximal shaft portion 106. Conversely, the first tapered section 108 can have an increasing diameter measured in a distal-to-proximal direction along the longitudinal axis A from the nose portion 102 to the region 109.

[0073] 8A, 8B, and 8C illustrate a cannulated reamer 120 that can be used to prepare the tibia or femur for a provisional stem housing and / or to remove initial bone to accept a cone / sleeve broach or a tibial keel broach. FIG. 8A illustrates a cannulated reamer 120 that can be used to remove bone from the proximal portion 12 of the tibia 10 to create the recess 72. FIGS. 8B and 8C are cross-sectional views of the cannulated reamer 120 within the tibia 10. The cannulated reamer 120 can include a cutting portion 122 and a shaft portion 123. FIGS. 8B and 8C also illustrate a stem provisional assembly 124 positioned within the recesses 72 and 16 of the tibia 10. The stem provisional assembly 124 can include a post extension 126, an adapter 128, and a stem extension 130. According to another embodiment, the stem temporary assembly 124 may include a post extension 126 and a monolith temporary stem (shown below).

[0074] 8B and 8C, a passageway 132 can be defined by the connecting portion 122 and the shaft portion 123. The passageway 132 can be configured to receive the post extension 126 of the stem provisional assembly 124. The post extension 126 can be configured to guide the cutting portion 122 of the cannulated reamer 120 into the tibia 10 to form the recess 72.

[0075] The post extension 126 can be positioned partially within the recess 72 and can extend proximally to a position above the tibia 10, as shown in FIG. 8C. The post extension 126 can be removably coupled to the adapter 128 by, for example, a threaded portion 133, as shown in FIG. 8C. The cannulated reamer 120 can also be positioned within the recess 72 over a proximal portion 134 of the adapter 128.

[0076] The adaptor 128 can be positioned within the recess 72 and can have a proximal portion 134 and a distal portion 136 disposed distally of the post extension 126. Figures 8B and 8C illustrate the stem subassembly 124, which can have an offset O imparted by the adaptor 128. In particular, the post extension 126 and the proximal portion 134 of the adaptor 128 can define a first longitudinal axis L1 that is offset by a distance O from a second longitudinal axis L2 defined by the stem extension 130 and the distal portion 136 of the adaptor 128. The offset O, as measured between the axes L1 and L2, can be in one or more directions, such as proximal, distal, medial, or lateral.

[0077] Stem extension 128 can be positioned within recess 16 and can be removably coupled to a distal portion 136 of adapter 128, for example, by threads 137 (FIG. 8C). Stem extension 128 extends distally of adapter 126 along recess 16.

[0078] 9A and 9B illustrate a drill guide 140 that can be used in preparation for broaching a cone or sleeve implant, in addition to the cannulated reamer 120 (FIGS. 8A-8C). In particular, the drill guide 140 can be configured to pre-drill bone to a desired shape and area prior to broaching a sleeve or cone component. Pre-drilling the bone using the drill guide 140 can reduce the risk of bone fracture during broaching. FIG. 9A illustrates the drill guide 140 attached to the post extension 126 of the stem provisional assembly 124 (FIG. 9B) to direct one or more drills 142 to remove bone from the proximal portion 12 of the tibia 10 to create a recess 72 (which can be larger than the recess created by the cannulated reamer 120 and can be proximal to the recess created by the offset broach 66 (FIGS. 4-6B) and / or the bevel reamer 100 (FIGS. 7A and 7B)). The drill guide 140 can be used to direct one or more drills 142 along a desired path to fracture bone around or along a designated area to create the recess 72 .

[0079] Drill guide 140 can include a coupling 144 and a body 146. Body 146 can include a plurality of apertures 148 ( FIG. 9A ) configured to receive one or more drills 142. FIG. 9B is a cross-sectional view of drill guide 140 showing a portion of body 146 with two apertures 148 and coupling 144. Coupling 144 has apertures and is configured to receive and rest on post extension 126. Coupling 144 can be connected to body 146 and can hold body 146 above tibia 10.

[0080] 9B shows the drill guide 140 attached to the post extension 126 proximal to the tibia 10 and recess 72. As shown in FIG. 9B, the drill guide 140 can be configured to direct one or more drills 142 distally into the tibia 10 on the anterior, posterior, medial, and / or lateral sides of the stem provisional assembly 124. The tips of the one or more drills 142 can be positioned adjacent to but spaced from the adapter 128. Each of the one or more drills 142 can include an enlarged diameter section 150 to limit the distal travel of the one or more drills 142 to avoid contact with the adapter 128.

[0081] Figures 10A-10E show the multi-purpose handle 50 previously shown in and described in connection with Figures 4-6B. Accordingly, the details of the handle 50 will not be discussed. Figures 10A-10E show the features previously discussed, including the distal tip 52 and the pin 54. Figures 10A-10D further show a biasing element 152 configured to position the pin 54 in an extended position. Figures 10A-10B also show one or more features 64 (e.g., protrusions) configured to engage with other instruments, such as the offset broach 66 of Figure 5 and the second temporary component 154 of Figures 10A-10E.

[0082] 10A and 10B show the handle 50 detached from the second temporary component 154, and FIGS. 10C-10E show the handle 50 engaged with the second temporary component 154. As shown in FIG.

[0083] 10A and 10B, the second temporary component 154 includes a recessed portion 156, a proximal surface 157 (FIG. 10A), and a lateral exterior surface 158. As shown in FIG. 10A, the recessed portion 156 can include a passageway 160 configured to allow the one or more features 64 to pass therethrough. The second temporary component 154 can further include one or more lips 162 formed in part by the proximal surface 157 that are designed to capture the one or more features 64 upon rotation (e.g., a quarter turn) of the handle 50 about the longitudinal axis L.

[0084] 10C-10D, when one or more features 64 are captured under one or more lips 162, the pin 54 can extend distally into the second recess 164. Such an arrangement can secure the second temporary component 154 to the handle 50 because the pin 54 restrains rotation of the second temporary component 154 about the longitudinal axis L (FIG. 10A).

[0085] The second provisional component 154 can be configured (e.g., have a size and shape along a lateral outer surface 158) to mimic the shape of at least one of the sleeve component or the cone component of the implant. In particular, the second provisional component 154 can be configured (can have a shape and size) to mimic the shape and size of the sleeve component of the implant. Another example is shown in Figure 21, which illustrates a provisional component configured to mimic the keel component of the implant.

[0086] As will be discussed and illustrated below, the recess 156 can comprise a through-hole from the proximal surface 157 to the distal surface 166 (FIGS. 10A-10C). The lateral outer surface 158 can extend from the proximal surface 157 to the distal surface 166. According to one embodiment, the second provisional component 154 can be configured as a broach. As such, the lateral outer surface 158 can include a plurality of cutting edges 168 (FIGS. 10C and 10D) that can be used with the handle 50 to at least partially create the recess in the tibia.

[0087] One or more portions of the outer lateral surface 158 and the recessed portion 156, according to one embodiment, can be tapered along its longitudinal length. Thus, the cross-sectional area of the distal portion of the second temporary component 154 can be different from and / or vary from the cross-sectional area of the proximal portion.

[0088] 11A shows an assembly 170 of the handle 50 together with the second temporary component 154 and the stem temporary assembly 124. FIG. 11B is an enlarged view of a portion of the assembly 170 including portions of the handle 50 and the stem temporary assembly 124.

[0089] 11A and 11B show the second temporary component 154 engaged with the handle 50. The second temporary component 154 can be configured to receive portions of the stem temporary assembly 124 therein. In particular, the post extension 126 and portions of the adapter 128 can be disposed in a recess 156 of the second temporary component 154. The adapter 128 can extend distally from the second temporary component 154. The post extension 126 extends proximally of the second temporary component 154 and is received within the handle 50. In particular, the handle 50 can be cannulated to receive the post extension 126 therein.

[0090] 11B, the post extension 126 can have a flared section 172 with a tapered outer surface 174 to interface with and seat within a first tapered inner surface 176 that forms a portion of the recess 156 of the second provisional component 154 when the post extension 126 is threaded to engage with the adapter 128. Additionally, the adapter 128 can include a tapered outer surface 178 configured to interface with and seat within a second tapered inner surface 180 that forms a portion of the recess 156 of the second provisional component 154 when the post extension 126 is threaded to engage with the adapter 128. The taper used by one or more of the post extension 126, the second provisional component 154, and the stem provisional assembly 124 can be self-retaining (e.g., a Morse taper or the like) in some embodiments. According to another embodiment, the taper used by one or more of the post extension 126, the second temporary component 154, and the stem temporary assembly 124 may be self-releasing.

[0091] 11C-11E illustrate a method 184 for placing the assembly 170 of FIGS. 11A-11B on the tibia 10. In particular, the assembly 170 is produced by the process described with reference to FIGS. 10A-11B. The method 184 can include coupling the second provisional component 154 to the handle 50 and can further include coupling the stem provisional assembly 124 (FIGS. 11C and 11D) to the second provisional component 154 via the tapered surface and threaded connection between the post extension and the adaptor discussed with reference to FIG. 11B. The coupling of the components to form the assembly 170 according to the method 184 can occur in vivo or outside the knee joint.

[0092] 11C-11D, the method 184 can include inserting the stem temporary assembly 124 and the second temporary component 154 into one or more recesses (e.g., recesses 72 and 16 in FIGS. 8B and 8C) such that the stem extension 130 can extend along the recess 16 (FIGS. 8B and 8C) and the second temporary component 154 can be inserted into the recess 72 (FIGS. 8B and 8C). The handle 50 can be configured to facilitate insertion of the stem temporary assembly 124 and the second temporary component 154.

[0093] Figure 12 shows a second assembly 186 comprised of the post extension 126, the second temporary component 154, and the stem extension 130, as previously described. Figure 12 also shows a second adapter 188 that has substantially no offset along its longitudinal length. As such, the second adapter 188 has a single longitudinal axis that extends the entire length of the second adapter 188.

[0094] 13 illustrates a cutting instrument 190, such as a saw, used to remove portions of bone in a resection to create a resection plane that includes the proximal surface 22 of the tibia 10. As shown in FIG. 13, the proximal surface 157 of the second temporary component 154 can be used to set the resection height of the proximal surface 22. In particular, the tibia 12 can be resected substantially horizontally using the proximal surface 157, with the blade of the cutting instrument 190 positioned over the proximal surface 157, so that the proximal surface 157 guides the removal of bone.

[0095] Figures 14A-14C illustrate a cutting guide assembly 192 that can be used with cutting instrument 190 (Figure 13). Cutting guide assembly 192 can be used in addition to or instead of the resection method of Figure 13. As shown in Figure 14B, cutting guide assembly 192 can include a first collar 194, a first arm 196, a second collar 198, a second arm 200, and a body 202.

[0096] As shown in FIG. 14B, the cutting guide assembly 192 can be assembled proximal to the second provisional component 154. The first collar 194 can include a boom that can be configured to couple with the post extension 126 or the reamer 14. The first collar 194 can be releasably locked to the post extension 126 or the reamer 14, for example, by turning a knob 204. A first arm 196 can be connected to the first collar 194 and can protrude from the first collar, including in a forward direction. A second collar 198 can be configured to receive the first arm 196. The second collar 198 can be movable along the length of the first arm 196 and can be releasably locked to the first arm, for example, by turning a second knob 206. As shown in FIG. 14C, the second collar 198 can have an opening 199 along a portion thereof. The opening 199 can facilitate removal of the components of the cutting guide assembly 192, including the first collar 194 and the first arm 196 (along with the reamer 14), without having to remove the body 202 from the bone. In particular, the opening 199 can be sized to allow the first arm 196 to pass through when not engaged by the second knob 206. Thus, the first arm 196 and the first arm 194 can be removed without changing the position of the body 202 relative to the bone.

[0097] 14B , the second arm 200 can be connected to the second collar 198 and extend generally distally to connect to the body 202. The body 202 can be positioned adjacent the anterior and proximal portion 12 of the anterior portion of the tibia 10. The body 202 can be adjusted in position relative to the tibia 10 using the first collar 194 and the second collar 198. The body 202 can be configured with a plurality of slots 208 and pinholes therein. A physician can select one or more of the plurality of slots 208 to guide the cutting instrument 190 ( FIG. 13 ) when performing resections to remove bone to create the proximal surface 22. In some embodiments, the plurality of slots 208 can be spaced apart from one another at set intervals (e.g., 5 mm increments).

[0098] FIGURE 15 is an enlarged view of a portion of the assembly 210, including the provisional tibial tray component 212, the fastener 214, the second provisional component 154, and the stem provisional assembly 124 (FIGS. 11A-11E). FIGURE 18 shows the assembly 210 with the provisional tibial tray component 212 mounted on the proximal surface 22 of the tibia 10. In FIGURE 18, the fastener 214 can be threaded to engage the stem provisional assembly 124 (e.g., FIGS. 11A-11E) to couple the provisional tibial tray component 212, the second provisional component 154 (FIG. 15), and the stem provisional assembly 124 (e.g., FIGS. 11A-11E) together.

[0099] 15 shows the tibial tray provisional component 212 and fasteners 214 removed from the second provisional component 154. The tibial tray provisional component can have apertures 216 configured to receive the fasteners 214 and can have distally extending protrusions 218 configured to mate with the second provisional component 154, as shown in FIG.

[0100] 16 illustrates a driver 220 that can be configured to engage various components of the assembly 210 (FIGS. 15 and 18), including the fastener 214 and the stem subassembly 124 (e.g., FIGS. 11A-11E). The driver 220 includes a first head portion 222, a handle 223, and a second head portion 224.

[0101] The first head portion 222 of the driver 220 can be configured to couple with and engage the fastener 214 to rotate the fastener 214 and actuate it into threaded engagement with the adapter 128 (e.g., FIGS. 11A-11E) to threadably couple the fastener 214 with the adapter 128, as shown in FIG. 17. The second head portion 224 is disposed opposite the first head portion 222 across the handle 223 and can have a different size than the first head portion 222. In particular, the second head portion 224 can be smaller than the first head portion 222 so as to be configured to access a portion of the adapter 128 distal to the portion with which the first head portion 222 engages, as described below with reference to FIG. 19.

[0102] 19 is a cross-sectional view of an assembly 210, which may include a provisional tibial tray component 212, a fastener 214, a second provisional component 154, and a stem provisional assembly 124, as previously described. The stem provisional assembly 124 may include an adaptor 128 and a stem extension 130. A similar assembly, but for the femur, is shown in FIGS. 26 and 26A.

[0103] As shown in FIG. 19 , the fastener 214 can extend through the aperture 216 and be at least partially received within the distally extending protrusion 218 of the provisional tibial tray component 212. The fastener 214 can extend into the threaded bore 225 of the adaptor 128 and can have a threaded portion configured to mate with the threaded portion of the threaded bore 225. The second provisional component 154 can be disposed about the distally extending protrusion 218 of the provisional tibial tray component 212. The proximal portion 134 of the adaptor 128 is received within the recess 156 of the second provisional component 154. The adaptor 128 and the stem extension 130 can extend distally of the provisional tibial tray component 212 and the second provisional component 154. The adaptor 128 can be configured to provide an offset along its longitudinal length, as described with reference to FIGS. 8B and 8C .

[0104] The fastener 214 can be threadably coupled to the proximal portion 134 of the adaptor 128 within the threaded bore 225. The distally extending protrusion 218 of the provisional tibial tray component 212 can have a tapered outer surface 226 that is tapered to interface with and seat within a first tapered inner surface 176 that forms a portion of the recess 156 of the second provisional component 154 when the fastener 214 is threadably secured to the adaptor 128. Additionally, the adaptor 128 can include a tapered outer surface 178 configured to interface with and seat within a second tapered inner surface 180 that forms a portion of the recess 156 of the second provisional component 154 when the fastener 214 is threadably secured to the adaptor 128. The taper utilized by one or more of the distally extending protrusion 218, the second provisional component 154, and the stem provisional assembly 124 can be self-retaining (e.g., a Morse taper or the like), according to some embodiments. According to another embodiment, the taper utilized by one or more of the distally extending projection 218, the second provisional component 154, and the stem provisional assembly 124 may be self-releasable.

[0105] 19 , the fastener 214 can include a passageway 228 therein. The passageway 228 can extend the entire longitudinal length of the fastener 214, can comprise a throughbore, and can be defined by a proximal portion 230, a central portion 232, and a distal portion 234. The central portion 232 of the fastener 214, which forms the passageway 228, can include a first engagement feature 236. The proximal portion 232 can be threaded along the passageway 228 (which can have internal threads) for coupling with a second fastener for locking to the tibial bearing component (not shown). The distal portion 234 can include external threads 238 configured to mate with the threaded hole 225.

[0106] The first engagement feature 236 can be configured to be engaged by the first head portion 222 of the driver 220 (FIG. 16). Such engagement facilitates rotation of the fastener 214 to couple or uncouple the fastener 214 from the adapter 128 via a threaded connection.

[0107] Additionally, the adaptor 128 may include a second engagement feature 240 disposed within the adaptor 128 distal to, but in fluid communication with, the threaded bore 225. The second engagement feature 240 may be configured for engagement by the second head portion 224 of the driver 220 (FIG. 16). Such engagement may facilitate movement of the provisional tibial tray component 212, as shown in FIGS. 23A and 23B, when a change in position of the provisional tibial tray component 212 is desired. This may allow the provisional tibial tray component 212 or the provisional femoral component 268 of FIG. 26A to better conform to the circumference of the tibia, as shown in FIGS. 23A and 23B (or the femur, in the case of a femoral provisional component, as shown in FIGS. 27 and 28). Engagement of the provisional stem assembly 124 with the driver 220 is shown in FIGS. 22A and 22B. Such engagement may allow for in vivo rotation of the provisional stem assembly 124, as shown in FIGS. 22A and 22B.

[0108] The second engagement feature 240 can be accessed by the driver 220 because the shaft and second head portion 224 can be small enough to pass through the passageway 228, including the first engagement feature 236 and the threaded hole 225, of the fastener 214 to access the second engagement feature 240. Thus, engagement to facilitate positioning of the provisional tibial tray component 212 and / or coupling or removal of the fastener 214 to the adapter 128 via the threaded connection can be performed with the driver 220 positioned most proximal to the provisional tibial tray component 212 (i.e., one of the positions shown in FIG. 17 ).

[0109] 17-23B for engagement to facilitate positioning and / or coupling or detachment of the fastener 214 with the adapter 128 via a threaded connection. This can be achieved with the tibial tray provisional component 212 positioned over the resected proximal surface 22 of the tibia 10 and the second provisional component 154 and stem provisional assembly 124 positioned within one or more recesses, as shown in FIGS. 17, 23A, and 23B. In the case of the femur, the femoral provisional component 268 (FIG. 26A) can be positioned in vivo, with the femoral provisional component 268 positioned over the resected distal surface of the femur and the second provisional component 154 and stem provisional assembly 124 positioned within one or more recesses of the femur.

[0110] As shown in Figures 23A and 23B, the position of the tibial tray provisional component 212 on the resected proximal surface 22 of the tibia 10 can be varied (indicated by arrow A1 in Figure 23A) by actuating a driver 220 (indicated by arrow A2 in Figure 23A) to engage and rotate the position of the stem provisional assembly 124 as shown in Figures 22A and 22B. This allows the positioning of the tibial tray provisional component 212 relative to the stem provisional assembly 124 on the resected proximal surface 22 after implantation of the second provisional component 154 and the stem provisional assembly 124. Use of a driver and stem provisional assembly 124 to adjust a femoral provisional component 268 (Figures 26-28) on the femur and / or use of a femoral sizing cut guide 262 (Figure 25) on the femur can also be envisioned.

[0111] 20 illustrates that once the desired relative positions of the various components of assembly 210 are achieved, assembly 210 can be removed from the patient together and placed on work surface 211. Notably, after assembly and in vivo alignment, assembly 210 can be removed from the patient while maintaining the position of each component relative to one another. This allows for easier and more timely generation of a permanent implant based on the temporary assembly, as the positions of the individual temporary components do not need to be documented or specified in detail. The entire temporary assembly, with the desired relative positions of each component relative to the others, can be maintained for easy reference.

[0112] Figure 21 shows another assembly 213 that can be assembled as described above, adjusted for position in vivo, and then removed together and placed on a work surface 211. The embodiment of Figure 21 includes a second temporary component 215 designed to mimic the configuration of a keel implant.

[0113] 24 shows an assembly 250 of components that can be assembled to comprise the stem subassembly 124 or other stem subassemblies. Alternatively, a monolithic version of the stem subassembly (integral adapter portion and stem extension) system can be provided as shown in FIG.

[0114] 24 , the system 250 can include a plurality of adapters 252 and a plurality of stem extensions 254. The plurality of adapters 252 can include a first adapter 128, a second adapter 188, and a third adapter 256. The plurality of stem extensions 254 can include a stem extension 130 and a second stem extension 258.

[0115] The multiple adapters 252 can be interchangeably used with the multiple stem extensions 254 to provide variable longitudinal offset. For example, the adapter 128 can provide a first amount of offset O1. The second adapter 188 can provide substantially no offset. The third adapter 256 can provide a third amount of offset O3 that is different from the offset O1 provided by the first adapter 128 and the no offset provided by the second adapter 188. According to one embodiment, the first offset O1 is 3 mm and the offset O3 is 6 mm.

[0116] The plurality of stem extensions 254 allows for variable longitudinal lengths. For example, stem extension 130 can have a longitudinal length of 135 mm, and stem extension 258 can have a longitudinal length of 175 mm. Various diameters for each of the plurality of stem extensions 254 can be provided as part of system 250.

[0117] The system 250 can be used interchangeably as a kit with either the tibial provisional or the femoral provisional to reduce the overall component count and thereby reduce the cost and weight of the provisional systems illustrated herein. According to other embodiments, different systems 250 are possible, for example, additional adapters with different offsets can be provided. According to some embodiments, rather than being modular, a one-piece stem provisional assembly is possible with the stem extension and adapter as a single component, as shown in FIG. 38.

[0118] Figure 25 shows a femur 260 along with a reamer 14, a femoral cut guide 262, and an offset coupler 24. The offset coupler 24 may have the configuration previously described with reference to Figures 3 and 3A. All of the instruments, components, systems, methods, and techniques previously described with reference to Figures 1-24 may be used with the femur 260 and the tibia 10 and are equally applicable.

[0119] 25, the offset coupler 24 is coupled to the reamer 14 and can be coupled to a femoral cut guide 262. The offset coupler 24 can be used as previously described in connection with FIGS. 3 and 3A to adjust the position of the femoral cut guide 262 as desired on the distal end portion 264 of the femur 250. The femoral cut guide 262 can comprise a 4-in-1 cut guide having multiple slots 256 configured to guide the resection of the distal end portion 264 of the femur 250 at various desired angles.

[0120] 26 and 26A show an assembly 266 including a femoral provisional component 268, a fastener 270 (FIG. 26A), a second provisional component 154, and a stem provisional assembly 124, as previously shown and described. The stem provisional assembly 124 includes an adaptor 128 and a stem extension 130.

[0121] Fastener 270 can be configured similarly to fastener 214 (FIG. 19) described above, but can have different longitudinal lengths and different configurations of proximal end portions because no support component needs to be coupled to fastener 262. Fastener 262 can include passageway 228 that provides access to adapter 128 to allow adjustment of the positioning of stem temporary assembly 124, as described above.

[0122] As shown in FIGS. 27 and 28 , according to some embodiments, the femoral provisional 268 can include an elongated slot 272. The elongated slot 272 can be configured to receive a pin 273 therein. The elongated slot 272 can be positioned to allow proximal-distal adjustment of the femoral provisional 268 at the end portion 264 of the femur 260, as shown in FIGS. 26 and 27 . In particular, with the pin 273 received in the elongated slot 272 in place, medial-lateral translation and internal-external rotation of the femoral provisional 268 can be constrained. However, the shape and orientation of the slot 272 can allow for adjustment of the proximal-distal position of the femoral provisional 268. Once the desired position of the femoral provisional 268 is achieved, a second pin (not shown) can be passed through the opening 274 and into the femur 260, thereby holding the femoral provisional 268 in the desired position.

[0123] The femoral provisional component 268 can include various slots for making augmentation cuts and, if desired, can include an intercondylar recess configured to mate with an insert for performing a box cut.

[0124] 29-32 show stem extension implants that are configured to be insensitive to stem rotation angle, allowing the stem extension implant to bend in any direction, in contrast to known slotted stem implants of the prior art that are configured to be direction sensitive, allowing the implant to bend in only a limited number of directions.

[0125] 29 shows another design of the distal portion of a stem extension implant 275 according to one embodiment. The stem extension implant 275 can include a helical passage 276 along a portion of its longitudinal length. Such a configuration can provide additional flexibility to the stem extension implant 275 if it is desired to not rely on a particular rotational placement in the bone.

[0126] 30 illustrates another design for the distal portion of a stem extension implant 278. The stem extension implant 278 can include a plurality of gaps 280 spaced apart from one another along a portion of the longitudinal length of the stem extension implant 278. The plurality of caps 280 create spaced apart sections 282 having a cross-sectional area that differs from the cross-sectional area of the plurality of gaps 280. Such a configuration can provide additional flexibility to the stem extension implant 278 when it is desired to not rely on a particular rotational placement in the bone.

[0127] 31 and 32 show yet another design for the distal portion of the stem extension implant 284. The stem extension implant 284 can include multiple slots 286 therein. These slots 286 can extend a portion of the longitudinal length of the stem extension implant 284 and can extend to its distal tip 288. The multiple slots 286 can separate the stem extension implant 284 into multiple sections 290, including a central section 292 and multiple outer sections 294. Such a configuration can provide additional flexibility to the stem extension implant 284 if desired, while increasing bending stiffness through contact of the 294 with the central core (288 or 292).

[0128] According to other embodiments, rather than having three slots 286 as shown, more or fewer slots may be used. For example, utilizing three slots 286 causes the central section 292 to have a generally triangular shape when viewed in cross section perpendicular to the longitudinal axis L, whereas if four slots are used, the central section may have a generally square shape.

[0129] FIG. 33 illustrates a method 300 according to one embodiment. Method 300 can utilize the systems, instruments, and components previously described with reference to FIGS. 1-32. According to one embodiment, method 300 can include a preoperative step, which can include imaging the knee joint using a medical imaging method, such as computed tomography (CT scan), X-ray, or magnetic resonance imaging (MRI), to obtain image data representative of the knee joint. The imaging data can be acquired or collected during the preoperative planning stage, according to some embodiments, based on two-dimensional or three-dimensional computerized images of corresponding anatomy reconstructed from image scans of the patient by computerized imaging methods. Such imaging can be used to identify diseased bone or tissue in the tibia and / or femur that requires removal, as well as implants that require removal in the case of a revision. The imaging can be used to identify one or more axes of the knee joint, such as the mechanical or anatomical axes of the tibia and femur. A model of the joint can be presented to the physician as part of the preoperative plan. The physician can review the three-dimensional model and, in some embodiments, provide instructions via electronic input.

[0130] In step 304, the joint may be exposed and the existing implant(s) removed. A preliminary joint assessment may also be performed 306. The tibial joint revision phase of method 300 may then be performed. The physician may identify 308 the mechanical axis of the tibia based on image data and / or observation and experience. A starter hole may also be created. The tibial tunnel (e.g., intramedullary canal, diaphysis, and / or metaphysis) may be prepared 310, for example, using the reamer 14 previously shown and discussed. An assessment 312 of the size and position of the tibia may be performed. If an offset stem provisional is desired, this or another stem provisional may be prepared and inserted 314 into one or more tibial recesses. Any desired drilling, broaching, or reaming may be performed 316, for example, using the instruments and / or techniques discussed in connection with FIGS. 5-10E. Resection of the proximal tibia may be performed 318, for example, using the instruments and / or techniques of FIGS. 13-14B. The provisional tibial tray component can be attached 320 and assembled as discussed with reference to Figures 15-23B. A joint assessment 322 can be performed. In some embodiments, the tibial assembly can be removed to create the implant assembly as discussed with reference to Figures 20 and 21.

[0131] The femoral joint revision phase of method 300 can then be performed. The physician can identify 324 the mechanical and / or anatomical axis of the femur based on image data and / or observation and experience. Starter holes can also be created. The femoral tunnel (e.g., intramedullary canal, diaphysis, and / or metaphysis) can be prepared 326, for example, using the reamer 14 previously shown and discussed. Assessment 328 of femoral size and position can be performed. If an offset stem provisional is desired, this or other stem provisional can be prepared and inserted 330 into one or more tibial recesses. Desired drilling, broaching, or reaming can be performed 332, for example, using the instruments and / or techniques discussed with reference to FIGS. 5-10E. Resection of the distal femur can be performed 334, for example, using the instruments and / or techniques of FIGS. 25-28. The femoral provisional can be attached 336 and assembled as discussed with reference to FIGS. 15-28.

[0132] The method 300 may further include initial trialing and reduction 338 and performing resections and box resections for femoral augmentation 340. The method 300 may also include patellar modification 342, which may stabilize the knee in flexion and extension, and a final trialing stage 343. The method 300 may conclude with insertion 344 of one or more implants.

[0133] Figure 34 shows further details of another method 350 that can be used as part of the method 300 of Figure 33. The method 350 can include shaping 352 a patient's bone to create one or more recesses in the bone. The method 350 can include assembling 354 a stem provisional assembly comprising an adaptor and a stem extension and placing 356 the stem provisional assembly within the one or more recesses. The method 350 can also include assembling 358 the stem provisional assembly in vivo with both a first provisional component configured to mimic the shape of one of a tibial tray implant or a femoral implant and a second provisional component configured to mimic the shape of at least one of a sleeve component or a keel component of the implant. In some embodiments, the assembling can include selecting an adapter from a plurality of adapters, each having a longitudinal axis extending between a proximal end and a distal end, the plurality of adapters including at least a first adapter with a longitudinal axis with no offset and at least a second adapter with a longitudinal axis offset by a predetermined amount, and selecting a stem extension from a plurality of stem extensions each configured to mate with the plurality of adapters, the plurality of stem extensions each having a different longitudinal dimension between the proximal end and the distal end. In another embodiment, the assembling can include one or more of threading a fastener into the threaded recess of the stem provisional assembly to engage the engager and passing a tool through the passage of the fastener to engage the stem provisional assembly distal to the threaded recess.

[0134] The method 350 may further include temporarily coupling the second provisional component and the stem provisional assembly together with a handle configured for insertion over the post extension and inserting the stem provisional assembly and the second provisional component together into the one or more recesses. According to one embodiment, the method 350 may include identifying a bone axis and determining whether an offset configuration is desired for the stem provisional assembly. According to one embodiment, the method 350 may include moving the stem provisional assembly in vivo to position the stem provisional assembly at a desired location within the one or more recesses and to position the first provisional component at the resected surface of the bone. According to one embodiment, the method 350 may include removing at least the tibial tray provisional component, the second provisional component, and the stem provisional assembly together from the bone and the one or more recesses while maintaining their respective positions relative to one another. Furthermore, the method 350 may include configuring an implant assembly based on the positions of the tibial tray provisional component, the second provisional component, and the stem provisional assembly.

[0135] 35A and 35B show an assembly 400 of a set screw 402, a fastener 402, and a component 404. The component 404 may practically include any orthopedic instrument or device, including, for example, the instruments and devices described herein, such as the drill guide 140 (FIGS. 9A and 9B), the offset coupler 24, and the femoral cut guide 262 of FIG.

[0136] 35A and 35B, the component can include a bore 406 having a threaded portion 408, a pocket portion 410, and a restriction 412. The fastener 402 can include a set screw having a head portion 414 and a threaded portion 416.

[0137] The bore 406 can be configured such that the threaded portion 408 is adjacent to and in communication with the pocket portion 410, and the pocket portion 410 is adjacent to and in communication with the restriction 412. The restriction 412 can be located at or adjacent to an opening 418 leading to the bore 406, according to some embodiments, although this arrangement may differ in other embodiments. The threaded portion 416 of the fastener 402 can be connected to the head portion 414.

[0138] 35A, the fastener 402 can be removed from the component 404 such that the threaded portion 408 does not engage the threaded portion 416. The fastener 402, including the threaded portion 416 and the head portion 414, can fit into the pocket portion 410 with some space 420 around it. In particular, the pocket portion 410 can be sized to receive the fastener 402 therein and provide space 420 between the sidewalls of the pocket portion 410 and the portions of the face of the fastener 402 that form the head portion 414 and the threaded portion 416. This space 420 allows access for a sterilizing solution to the threaded portion 408, the pocket 410, and the fastener 402 around the head portion 414, for example, through an opening 418.

[0139] FIG. 35A illustrates that the pocket portion 410 can have a larger diameter than the head portion 414 to provide a certain amount of spacing from the head portion 414. However, the restriction 412 can have a diameter that is substantially equal to or slightly smaller than the head portion 414. In this case, an interference fit is created between the restriction 412 and the head portion 414. In FIG. 35A , the fastener 402 is inserted into the pocket portion 410 through the interference fit. Such insertion can be achieved, for example, by using flexible materials for the components and / or fastener, applying sufficient force to the fastener 402 for insertion, or applying a temperature differential between the fastener and the component (causing expansion and / or contraction). To facilitate such insertion, the head portion 414 can include a chamfered surface 422 that can act as a ramp to facilitate insertion of the fastener 402 into the restriction 412. Additionally or alternatively, the restriction 412 can include a chamfered surface 424 that can act as a ramp. In embodiments where both chamfered surfaces 424 and 422 are utilized, chamfered surface 422 can be shaped and positioned to initially interact with chamfered surface 424 upon insertion of fastener 402 into pocket portion 410.

[0140] Once captured within the pocket portion 410, the restriction 410 can be configured (relatively sized) relative to the head portion 414 such that the interference fit between the restriction 410 and the head portion 414 prevents the fastener 402 from moving back out of the hole 406 beyond the restriction 412. Thus, the fastener 402 cannot be removed once inserted into the pocket portion 410 and can be retained by the restriction 410.

[0141] 35B shows fastener 402 after it has been engaged and turned at engagement feature 426 of head portion 414 to engage threaded portion 416 with threaded portion 408. Such threaded engagement can, for example, clamp two portions of component 404 together.

[0142] Figures 36A and 36B illustrate another assembly 430 having a configuration very similar to that of assembly 400 of Figures 35A and 35B. Accordingly, certain features of assembly 430 will not be described in detail, including features discussed with reference to Figures 35A and 35B. The embodiment of Figures 36A and 36B differs from the embodiment of Figures 35A and 35B in that passages 432A and 432B are provided in fluid communication with pocket portion 410. These passages 432A and 432B extend substantially transverse to the longitudinal axis of bore 406, for example. Passages 432A and 432B facilitate the passage of sterilizing solution, if desired.

[0143] FIGS. 37A and 37B illustrate two drivers 450A and 450B that can be used in place of the driver 220 of FIG. 16. The driver 450A of FIG. 37A can be configured to engage various components of the assembly 210 (FIGS. 15 and 18), such as the fastener 214. Accordingly, the driver 450A can include a first head 222 and a handle 223, as described above. The first head 222 of the driver 450A can be configured to couple with and engage the fastener 214, for actuation to rotate the fastener 214 into threaded engagement with the adapter 128 (FIGS. 11A-11B), as shown in FIG. 17. According to the embodiment of FIG. 37A, the first head 222 can include a 5 mm hex head.

[0144] The driver 450B of FIG. 37B can include a handle 223 and a second head 224. The driver 450B can be configured to engage the stem temporary assembly 124, as previously described with reference to FIGS. 11A-11E and 22A-22B. The second head 224 can have a different size than the first head 222 ( FIG. 37A ). In particular, the second head 224 can be smaller than the first head 222 (e.g., a 3 mm hex head) so as to be configured to access a portion of the adapter 128 distal to the portion engaged by the first head 222, as discussed in connection with FIG. 19 .

[0145] 38 shows a system 460 of monolith components that can be assembled to include, for example, a stem subassembly, which can be used in place of the modular system of FIG. 24 (separate adapters and stem extensions).

[0146] The system 460 can utilize a monolithic version of the stem subassembly (ie, comprising a single component having one adapter portion 462A, 462B, 462C and one stem extension portion 464A and 464B) as shown in FIG.

[0147] In reference plane, the system 460 can include a plurality of components 466, 468, 470, 472, 474, and 476. Each of the plurality of components 466, 468, 470, 472, 474, and 476 can have one of a plurality of adapter portions 462A, 462B, 462C and one of a plurality of stem extension portions 464A and 464B.

[0148] The plurality of stem extensions 464A and 464B can be configured to provide various longitudinal lengths. For example, stem extension 464A can have a longitudinal length of 135 mm, and stem extension 464B can have a longitudinal length of 175 mm. Various diameters of each of the plurality of stem extensions 464A and 464B can be provided as part of system 460.

[0149] The adapter portions 462B can be configured to provide different amounts of longitudinal offset. For example, the adapter portion 462B can provide a first amount of offset O1. The adapter portion 462A has substantially no offset. The third adapter portion 462C can provide a third amount of offset O3 that is different from the offset O1 and no offset provided by the adapter portions 462A and 462B. According to one embodiment, the first offset O1 is 3 mm and the offset O3 is 6 mm.

[0150] Additional notes The above description refers to the accompanying drawings, which form a part hereof. The drawings show, by way of illustration, specific embodiments in which the invention may be practiced. These embodiments are also referred to herein as "embodiments." These embodiments may include elements in addition to those shown or described. However, the inventors also contemplate embodiments including only those elements shown and described. Furthermore, the inventors also contemplate embodiments (or one or more embodiments thereof) using any combination or permutation of the elements shown or described in connection with the particular embodiment (or one or more embodiments thereof) or in connection with any other embodiment (or one or more embodiments thereof) shown or described herein.

[0151] As used herein, the singular articles "a" and "an" are used, as is common in patent documents, to include one or more, regardless of other instances or uses of "at least one" or "one or more." In this application, "or" is used non-exclusively, and unless otherwise indicated, "A or B" includes "A but not B," "B but not A," or "A and B." As used herein, "including" and "in which" are used as the plain English equivalents of "comprising" and "wherein," respectively. Also, in the claims, "including" and "comprising" are open-ended, and systems, devices, items, compositions, formulations, or processes that include additional elements in addition to the elements listed before "comprising" in the claims are also considered to be within the scope of the claims. Furthermore, in the claims, "first," "second," "third," etc. are used merely as labels and do not impose numerical requirements on their objects.

[0152] The above description is illustrative, not limiting. For example, the above-described embodiments (or one or more aspects thereof) can be used in combination with each other. Those skilled in the art will be able to use other embodiments upon reviewing the above description. The Abstract is provided to enable the reader to quickly ascertain the contents of the disclosure in accordance with 37 CFR §1.72(b). It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Furthermore, in the above description, various features may be grouped together to streamline the disclosure. This should not be construed as intending that an unclaimed, disclosed feature is essential to any claim. The subject matter of the present invention may include less than all features of a particular disclosed embodiment. Accordingly, the claims are intended to be incorporated into the Detailed Description of the Invention as examples or embodiments, with each claim standing on its own as a separate embodiment, and these embodiments can be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full range of equivalents to which the claims are entitled. According to aspect (1), there is provided an angled reamer for removing bone to create a recess, comprising: a proximal shaft portion; a distal nose portion; and a cutting portion coupled to the proximal shaft portion and the distal nose portion, the cutting portion having a back angle taper that decreases in diameter measured in a distal-to-proximal direction along a longitudinal axis of the bevel reamer; The bevel reamer includes: According to aspect (2), the distal nose portion has a blunt tip. According to aspect (3), the cutting portion has a first tapered section having a first angle measured from the longitudinal axis, and the back angle taper is a second tapered section having a second angle measured from the longitudinal axis. According to aspect (4), the first tapered section is separated from the second tapered section by a region having a maximum diameter of the cutting portion. According to aspect (5), the first angle is inverted with respect to the second angle. According to aspect (6), there is provided a system for removing bone to create a recess, comprising: a cannulated reamer having a cutting portion and a shaft portion coupled to the cutting portion; a stem provisional assembly configured for insertion into the intramedullary canal of the bone, the cutting portion and the shaft portion configured to receive at least a post extension of the stem provisional assembly, the post extension of the stem provisional assembly configured to guide the cutting portion into the bone to form the recess; The system includes: According to aspect (7), the implant further comprises a drill guide configured to be attachable to the stem provisional assembly and configured to pre-drill holes in the bone before breaching. According to aspect (8), the drill guide is configured to direct one or more drills along multiple desired paths to fracture the bone along designated areas and form the recesses. According to aspect (9), the plurality of desired passages are at an acute angle to the axis of the post extension of the stem temporary assembly. According to aspect (10), the drill guide has a body with a plurality of spaced apart openings configured to receive the one or more drills. According to aspect (11), the stem provisional assembly includes an adapter configured to be placed in the recess, the adapter being coupled between the post extension and the stem extension, and the drill guide being configured to limit the stroke of the one or more drills adjacent to the adapter. According to aspect (12), the beveled reamer further includes a distal nose portion and a cutting portion, the cutting portion having a back angle taper that decreases in diameter measured in a distal-to-proximal direction along a longitudinal axis of the beveled reamer. According to aspect (13), a first provisional component has a proximal surface and a distal surface opposite the proximal surface, and one of the distal surface and the proximal surface is configured to be placed on a resected surface of a bone; a second provisional component configured to be placed in the recess below the resected surface of the bone, the second provisional component configured to mimic the shape of at least one of a sleeve component, a cone component, or a keel component of an implant; and a fastener configured to join the first temporary component, the second temporary component, and the stem temporary assembly together as an assembly, the fastener including a passageway for allowing access to the stem temporary assembly from adjacent first temporary components; It has. According to aspect (14), the implant further comprises a handle configured to temporarily engage the second provisional component with the stem provisional assembly, and when temporarily engaged with the handle, the second provisional component and the stem provisional assembly can each be inserted into the recess of the bone. According to aspect (15), the present invention further includes a single or multiple drivers, and the single or multiple drivers include: engaging the fastener to thread it into the threaded recess of the stem subassembly; and passing the fastener through the passage to engage the stem provisional assembly, wherein engagement between the driver and the stem provisional assembly rotates the stem provisional assembly in vivo and positions the first provisional component at the resection surface; The method is configured to perform at least one of the following: According to aspect (16), the fastener, the first provisional component, the first provisional component, and the stem provisional assembly are removable from the bone together as an assembly while maintaining the position of each component relative to one another. According to aspect (17), the first provisional component includes a femoral component having an elongated slot configured to receive a pin therein, the elongated slot configured to allow proximal-distal movement of the femoral component relative to the pin. According to aspect (18), the stem temporary assembly includes: a plurality of adapters having a longitudinal axis extending between a proximal end and a distal end, the plurality of adapters including at least a first adapter having no offset in the longitudinal axis and at least a second adapter having some offset in the longitudinal axis; a plurality of stem extensions, each configured to interchangeably couple with the plurality of adapters, each of the plurality of stem extensions having a different longitudinal extent between a proximal end and a distal end; Equipped with the second adapter comprises two adapters, one adapter having a first offset amount and the other adapter having a second offset amount different from the first offset amount; It is a system.

Claims

1. 1. An angled reamer for removing bone to create a recess, comprising: a proximal shaft portion; a non-cutting distal nose portion having a length between 15 mm and 70 mm; a cutting portion coupled to the proximal shaft portion and the distal nose portion, the cutting portion having a back angle taper that decreases in diameter measured in a distal-to-proximal direction along a longitudinal axis of the bevel reamer; Including, angled reamers.

2. The angled reamer of claim 1 , wherein said distal nose portion has a blunt tip.

3. 2. The bevel reamer of claim 1, wherein said cutting portion has a first tapered section having a first angle measured from said longitudinal axis, and said back angle taper is a second tapered section having a second angle measured from said longitudinal axis.

4. 4. The angled reamer of claim 3, wherein said first tapered section is separated from said second tapered section by a region having a maximum diameter of said cutting portion.

5. 4. The bevel reamer of claim 3, wherein said first angle is inverted relative to said second angle.

6. 1. A system for removing bone to create a recess, comprising: The bevel reamer of claim 1 having the distal nose portion and the cutting portion; a cannulated reamer having the cutting portion and a shaft portion coupled to the cutting portion; a stem provisional assembly configured for insertion into an intramedullary canal of the bone, the cutting portion and the shaft portion configured to receive at least a post extension of the stem provisional assembly, the post extension of the stem provisional assembly configured to guide the cutting portion into the bone to form the recess; Including, the system.

7. The system of claim 6 , further comprising a drill guide configured to be attachable to the stem provisional assembly and configured to pre-drill the bone prior to breaching.

8. 8. The system of claim 7, wherein the drill guide is configured to direct one or more drills along a plurality of desired paths to fracture the bone along designated areas and form the recesses.

9. The system of claim 8 , wherein the plurality of desired paths are at an acute angle relative to an axis of the post extension of the stem provisional assembly.

10. The system of claim 8 , wherein the drill guide has a body with a plurality of spaced apart openings configured to receive the one or more drills.

11. 11. The system of claim 10, wherein the stem temporary assembly includes an adapter configured to be positioned in the recess, the adapter coupled between the post extension and the stem extension, and the drill guide configured to limit a stroke of the one or more drills adjacent the adapter.

12. a first provisional component having a proximal surface and a distal surface opposite the proximal surface, one of the distal surface and the proximal surface configured to be positioned on the resected surface of the bone; a second provisional component configured to be placed in the recess below the resected surface of the bone, the second provisional component configured to mimic the shape of at least one of a sleeve component, a cone component, or a keel component of an implant; and a fastener configured to join the first temporary component, the second temporary component, and the stem temporary assembly together as an assembly, the fastener including a passageway for allowing access to the stem temporary assembly from adjacent first temporary components; The system of claim 6 , comprising:

13. 13. The system of claim 12, further comprising a handle configured to temporarily engage the second provisional component with the stem provisional assembly, wherein when temporarily engaged with the handle, the second provisional component and the stem provisional assembly are each insertable into the recess of the bone.

14. Further, the single or multiple drivers may be engaging the fastener to thread it into the threaded recess of the stem subassembly; and passing the fastener through the passage to engage the stem provisional assembly, wherein engagement between the driver and the stem provisional assembly rotates the stem provisional assembly in vivo and positions the first provisional component on the resection surface; The system of claim 12 , configured to perform at least one of the following:

15. 13. The system of claim 12, wherein the fastener, the first provisional component, the first provisional component, and the stem provisional assembly are removable from the bone together as an assembly while maintaining the position of each component relative to one another.

16. 13. The system of claim 12, wherein the first provisional component comprises a femoral component having an elongated slot configured to receive a pin therein, the elongated slot configured to allow proximal-distal movement of the femoral component relative to the pin.

17. The stem temporary assembly includes: a plurality of adapters having a longitudinal axis extending between a proximal end and a distal end, the plurality of adapters including at least a first adapter having no offset in the longitudinal axis and at least a second adapter having some offset in the longitudinal axis; a plurality of stem extensions, each configured to interchangeably couple with the plurality of adapters, each of the plurality of stem extensions having a different longitudinal extent between a proximal end and a distal end; Equipped with the second adapter comprises two adapters, one adapter having a first offset amount and the other adapter having a second offset amount different from the first offset amount; The system of claim 6 .

18. The bevel reamer of claim 1 , wherein the non-cutting distal nose portion has an elongated length for referencing the intramedullary canal of a bone.

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