RU2772936C2 - Method and instruments for assembly of orthopedic prosthesis - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: method for the assembly of a tibial component of a knee joint prosthesis, according to the first option, includes the use of a tibial test structure and a surgical instrument. The tibial test structure contains a test base that forms the first axis and a test displacement adapter that forms the second axis offset relatively to the first axis. The surgical instrument includes a support platform and a stabilizing bracket. The tibial displacement adapter includes the distal end, which forms the fourth axis offset relatively to the third axis. Actions of the method, according to the first option, include the combination of the tibial test structure with the surgical instrument, placement of the tibial test structure on the support platform, rotation of the support platform to place the first axis and the second axis in a plane passing vertically through the stabilizing bracket, extension of the stabilizing bracket along the vertically passing plane to engage the stabilizing bracket with the tibial test structure, locking of the support platform to prevent rotation relatively to the stabilizing bracket, placement of the tibial prosthesis component on the support platform after removal of the tibial test structure so that the third axis formed by a distal pin of the tibial prosthesis component is located in the plane, placement of the tibial displacement adapter on the distal pin, rotation of the distal end of the tibial displacement adapter to place the fourth axis in the vertically passing plane, and attachment of the tibial displacement adapter to the tibial prosthesis component, while the third axis and the fourth axis are located in the plane. The method for the assembly of the tibial component of the knee joint prosthesis, according to the second option, includes the rotation of the support platform of the surgical instrument around a vertically passing axis, attachment of a holder to the support platform, placement of the first tibial prosthesis component on the holder, while the first tibial component includes a tibial groove and a pin extending from the tibial groove, extension of the first clamping bar of the holder into engagement with the tibial groove to attach the tibial groove between the first clamping bar and the second clamping bar of the holder, and the attachment of the second tibial prosthesis component on the pin of the first tibial prosthesis component, wherein the attachment of the second tibial prosthesis component to the pin of the first tibial prosthesis component includes a shift of the second tibial prosthesis component along a tapering outer surface of the pin for attachment of the second tibial prosthesis component to the pin, while the second tibial prosthesis component includes a stepped outer surface, wherein the attachment of the second tibial prosthesis component to the pin of the first tibial prosthesis component additionally includes the connection of the first end of an impactor to the distal end of the second tibial prosthesis component and the application of force to the second end of the impactor. The method for the assembly of the tibial component of the knee joint prosthesis, according to the third option, includes the use of a test prosthesis node and a surgical instrument. The surgical instrument includes a support platform and a stabilizing bracket. The test prosthesis node contains a test prosthesis component, which forms the first axis, and a test displacement adapter, which forms the second axis offset relatively to the first axis. The displacement adapter includes an end that forms the fourth axis offset relatively to the third axis by amount equal to the offset of the first axis and the second axis. Actions of the method, according to the third option, include the combination of the test prosthesis node with the surgical instrument, placement of the trial prosthesis node on the support platform, rotation of the support platform to place the first axis and the second axis in a plane passing vertically through the stabilizing bracket, extension of the stabilizing bracket along the vertically passing plane to engage the stabilizing bracket with the test prosthesis node, locking of the support platform to prevent rotation relatively to the stabilizing bracket, location of the prosthesis component on the support platform after removal of the test prosthesis node so that the third axis formed by the pin of the prosthesis component is in the plane, while dimensions and shape of the prosthesis component correspond to dimensions and shape of the test prosthesis node, placement of the displacement adapter on the pin, rotation of the end of the displacement adapter to place the fourth axis in the vertically passing plane, and attachment of the displacement adapter to the prosthesis component, while the third axis and the fourth axis are located in the plane.

EFFECT: inventions provide the possibility of assessment of the fit, range of movement and other parameters of the patient’s joint and helping the surgeon in choosing components of an orthopedic prosthesis for implantation.

19 cl, 47 dwg

Description

cross reference

[0001] Cross references are made to U.S. Patent Application No. XX/XXX,XXX entitled Orthopedic System and Method for Assembling Prosthetic Components and U.S. Patent Application No. XX/XXX,XXX entitled Method and Instruments for Assembling a Femoral Orthopedic Prosthesis , which were filed on the same day as this application and are expressly incorporated into this application by reference.

Technical field

[0002] The present disclosure pertains generally to orthopedic instruments for use in an orthopedic joint replacement operation, and in particular to orthopedic surgical instruments for use in a knee replacement procedure.

BACKGROUND OF THE INVENTION

[0003] Arthroplasty of the joints is a well-known type of surgical intervention that allows you to replace the affected and/or damaged natural joint with a joint endoprosthesis. For example, in total knee arthroplasty surgery, the patient's natural knee joint is partially or completely replaced with a knee prosthesis or knee prosthesis. A standard knee prosthesis includes a plurality of prosthesis components, including a tibial trough, a femoral component, and a polymeric liner or support component positioned between the tibial trough and the femoral component. The tibial groove essentially includes a plate with a rod extending distally from it, and the femoral component essentially includes a pair of spaced condylar elements that include surfaces that articulate with corresponding surfaces of the polymeric support component. The tibial gutter shaft is designed to be implanted into the surgically prepared bone marrow cavity of the patient's tibia, and the femoral component is made to be connected to the surgically prepared distal end of the patient's femur.

[0004] Sometimes it becomes necessary to perform revision surgery on the patient's knee. In such revision knee surgery, a previously implanted knee prosthesis is surgically removed and a replacement knee prosthesis is implanted. In some knee revision surgeries, all components of a previously implanted knee prosthesis may be surgically removed, including, for example, the tibial trough, the femoral component, and the resin support component. In other knee revision surgeries, only a portion of a previously implanted knee prosthesis may be removed and replaced.

[0005] During any knee surgery, an orthopedic surgeon typically uses a variety of different orthopedic surgical instruments, such as, for example, cutting blocks, drills, drilling guides, and other surgical instruments, to prepare the patient's bones for a knee prosthesis. The surgeon may also use orthopedic surgical instruments, such as trial prosthesis components, to size fit and select appropriate prosthesis components. Such trial prosthesis components are shaped to match the size and shape of their respective prosthesis components, but are not designed to be permanently implanted in the patient's bone. Instead, trial prosthesis components may be temporarily placed in place of prosthetic components during surgery on the patient's bones to evaluate the fit, range of motion, and other parameters of the patient's joint and assist the surgeon in selecting prosthetic prosthesis components for implantation.

SUMMARY OF THE INVENTION

[0006] In accordance with one aspect of the description, an orthopedic system and method for replacing a patient's knee joint is provided. The system includes surgical instruments used to assemble an orthopedic prosthesis. In some embodiments, the system may also include trial prosthesis components that can be used to size and select orthopedic prosthesis components. The system may include orthopedic prosthesis components such as, for example, a femoral prosthesis component, a tibial prosthesis component, a prosthetic shaft component, and a prosthesis sleeve component.

[0007] Orthopedic surgical instruments may include an instrument base configured to receive a trial prosthesis holder. The trial prosthesis holder may be configured to secure the trial prosthesis component to the base of the instrument. It should be understood that the system may include a plurality of trial prosthesis holders, each configured to accommodate different configurations of the trial prosthesis component. In some embodiments, prosthetic trial component configurations may include a femoral trial component sized and shaped to match the dimensions and shape of the femoral prosthesis component, a tibial trial rig sized and shaped to match the dimensions and shape of the tibial prosthesis component, and a shank trial component sized and shape corresponding to the size and shape of the prosthesis rod.

[0008] In some embodiments, the tool base may be configured to receive a prosthesis component holder that is configured to secure the prosthesis component to the tool base. It should be understood that the system may include multiple prosthesis component holders, each of which is configured to accommodate different configurations of the prosthesis component. It should be understood that, in some embodiments, the same holder may be configured to selectively attach the trial prosthesis component and the corresponding prosthesis component to the instrument base.

[0009] Orthopedic surgical instruments may include a stabilizing or support arm configured to attach to the base of the instrument. The support bracket may be configured to engage a portion of the trial prosthesis component and/or a portion of the prosthesis component during assembly to hold the trial prosthesis component or prosthesis component in position during assembly.

[0010] In some embodiments, the surgical instrument system may further comprise an open-ended wrench that is sized to accommodate the femoral sleeve. The open mouth may be formed by a plurality of key surfaces. The key may also include a plurality of protrusions extending from the surfaces into the open throat. Each protrusion may be shaped to grip the surface of the femoral sleeve.

[0011] In accordance with another aspect of the description, a surgical instrument system for selecting and assembling a patient's orthopedic knee prosthesis is provided. The surgical instrument system comprises a base with a support platform, a first holder including a support block selectively mounted on the support platform, and a second holder configured to be selectively mounted on the support platform instead of the first holder. The first holder includes a pin extending at a non-orthogonal angle relative to the support block, and such a pin includes a distal end sized to accommodate the femoral component of the prosthesis in the passage. The second holder includes a first clamp bar and a second clamp bar that are movable to grip a tibial prosthesis component between the first clamp bar and the second clamp bar.

[0012] In some embodiments, the surgical instrument system may further comprise a third holder that is configured to secure the femoral trial component to the base. The third holder may include a support block configured to be selectively placed on the support platform in place of the first holder and the second holder. The third holder may further include a pin extending at an orthogonal angle with respect to the support block to the distal end. The distal end of the pin of the third holder may include a flat end surface and a pin extending from the end surface, which is sized to accommodate a femoral trial component corresponding to the prosthesis femoral component in the recess. In some embodiments, the implementation of the hairpin may be configured to receive in the fastener of the femoral component of the prosthesis.

[0013] In some embodiments, the implementation of the first holder may further include a pair of walls connected to the pin and extending outward from the support block. The walls can be made with the possibility of placement in the intercondylar slot of the femoral component of the prosthesis. In addition, in some embodiments, the implementation of the third holder may also include a pair of walls connected to the pin and extending outward from the support block. The walls may be sized to fit into the intercondylar slit of the femoral trial component.

[0014] It should be noted that, in some embodiments, the surgical instrument system may further include a liner with a channel extending along a first axis and a thickness that is formed along a second axis extending orthogonally to the first axis. The thickness of the pad may correspond to the width of the intercondylar slit of the femoral component of the prosthesis and/or of the femoral trial component. The size of the channel may accommodate each wall of the pair of walls of the first holder and/or the third holder to selectively mount the gasket on each wall.

[0015] In addition, in some embodiments, the gasket may include an opening and a pair of side surfaces that extend inwardly from the opening to the surface of the base. The pair of side surfaces and the base surface may together form a channel in the gasket. The gasket may further include a groove formed on one side surface of the pair of side surfaces and extending along the first axis. In some embodiments, each wall of the wall pair may include a rib extending outward from the first planar surface. The rib of each wall may be sized to fit within the gasket groove to allow the gasket to be installed in only one orientation on each wall. In some embodiments, the rib of one wall may extend in the same direction as the rib of the other wall.

[0016] In some embodiments, the pad may be one of multiple pads. Each pad may have a different thickness than the other pads of the plurality of pads, and each thickness may correspond to the width of the intercondylar slit of one of the plurality of femoral prosthesis components.

[0017] As described above, the surgical instrument system includes a second holder configured to receive a tibial prosthesis component. In some embodiments, the second holder may include a screw mechanism for moving the second clamp bar and the first clamp bar. One of the first clamp bar and the second clamp bar of the second holder may include a concave curved wall shaped to engage with the convex curved anterior wall of the tibial prosthesis component. The other of the first clamp bar and the second clamp bar may include a convex curved wall that is between and connected to a pair of concave curved walls. The convex curved wall and the pair of concave curved walls may be shaped to engage the posterior wall of the tibial prosthesis component.

[0018] In some embodiments, the second clip of the second holder may include a rear slot sized to receive a posterior protuberance of the tibial prosthesis component and an anterior slot sized to accommodate an anterior protrusion of the tibial prosthesis component.

[0019] In some embodiments, the base of the surgical instrument system may include a fixed body, and the support platform may be rotatably coupled to the stationary body to allow the support platform to rotate 360 degrees about a vertical axis relative to the stationary body. In some embodiments, the base may further include a locking cam configured to prevent rotation of the support platform relative to the fixed body.

[0020] In some embodiments, the surgical instrument system may further include a support or stabilizing arm located above the base. The support bracket can be connected to the fixed body. In addition, the support bracket may be movable in a horizontal plane relative to the support platform.

[0021] In accordance with another aspect of the present disclosure, a surgical instrument system for selecting and assembling an orthopedic prosthesis for a patient's knee joint comprises a base including a fixed body, a support platform that is rotatably coupled to the stationary body to allow rotation of the support platform on 360 degrees around a vertical axis passing through the fixed body, and a blocking cam configured to prevent the support platform from rotating relative to the fixed body. The surgical instrument system also includes a support arm removably coupled to the fixed body. The support bracket is movable in a horizontal plane relative to a vertical axis. The surgical instrument system further comprises a plurality of trial prosthesis holders configured to be separately connected to the support platform for rotation along with the support platform. Each trial prosthesis holder is configured to accommodate a trial prosthesis component with the shape and dimensions corresponding to the prosthetic component of the orthopedic prosthesis.

[0022] In some embodiments, the support bracket may include an elongate body located in a horizontal plane, a first shaft located in a horizontal plane and extending outward from the elongate body to a proximal tip, and a second shaft extending outward from the elongate body parallel to the first shaft. to the proximal tip. A channel may be formed between the proximal tips of the first shaft and the second shaft. The size of the channel provides for the placement of a portion of the trial prosthesis component located on one of the trial prosthesis holders when the trial prosthesis holder is connected to the support platform. In addition, in some embodiments, the surgical instrument system may further include a user-operated handle configured to move the first shaft toward the second shaft to reduce the width of the channel.

[0023] In some embodiments, the support platform may include a pair of upwardly extending studs. Each trial prosthesis holder may include a pair of holes sized to accommodate the upwardly extending pins separately. Furthermore, in some embodiments, one of the upwardly extending hairpins has a different configuration (eg, size and/or shape) from the other upwardly extending hairpin such that the prosthesis trial holder can only be mounted on the support platform in one orientation.

[0024] In some embodiments, the surgical instrument system may further comprise a femoral trial component configured to be mounted on at least one of the trial prosthesis holders. The femoral trial component may include a pair of convex, curved condylar surfaces. The system may also include an adapter component configured to attach to the proximal end of the femoral trial component and a rod trial component configured to attach to the proximal end of the adapter. The size of the support bracket channel may accommodate the adapter component.

[0025] In some embodiments, the implementation of the system may include a gasket with a channel passing along the first axis, a thickness that is formed along the second axis, passing orthogonally to the first axis. The thickness of the pad may correspond to the width of the intercondylar slit of the femoral trial component, and the size of the channel may accommodate the wall of at least one of the trial prosthesis holders to allow the pad to be placed on the trial prosthesis holder.

[0026] In some embodiments, the adapter component may include visual indicators placed to correctly position the support arm elongate body when the adapter component is positioned in the support arm channel.

[0027] In accordance with another aspect, a surgical instrument system for assembling an orthopedic prosthesis for a patient's knee joint comprises a base including a fixed body, as well as a support platform that is rotatably connected to the fixed body to allow the support platform to rotate 360 degrees about a vertical axis passing through the fixed body. The surgical instrument system also includes a support arm removably coupled to the fixed body. The support bracket is movable in a horizontal plane relative to a vertical axis. The surgical instrument system further comprises a prosthesis component holder configured to be connected to the support platform for rotation along with the support platform. The prosthesis component holder is configured to accommodate the prosthesis component of the orthopedic prosthesis.

[0028] In some embodiments, the base may further include a locking cam configured to prevent the support platform from rotating relative to the fixed body.

[0029] In some embodiments, the adapter component may include visual indicators placed to correctly position the support arm elongate body when the adapter component is positioned in the support arm channel.

[0030] In some embodiments, the prosthesis component holder may be one of a plurality of prosthesis component holders. Each prosthesis component holder can be configured to accommodate a different configuration of a prosthesis component. It should be understood that prosthesis component configurations may include a femoral prosthesis component or a tibial prosthesis component.

[0031] In accordance with another aspect of the description, the orthopedic system may include any of the surgical instrument systems described above. As described above, the prosthetic system may also include prosthesis components that form an orthopedic prosthesis and prosthetic trial components corresponding to the prosthesis components.

[0032] According to another aspect, a method for assembling an orthopedic prosthesis is described. The method includes combining a tibial trial construction with a surgical instrument, which includes a support platform and a stabilizing arm. The tibial trial design includes a trial base that forms a first axis and a trial offset adapter that forms a second axis offset from the first axis. The method also includes placing the tibial trial structure on the support platform, rotating the support platform to transfer the first axis and the second axis to a plane passing vertically through the stabilizing bracket, extending the stabilizing bracket along the vertically passing plane to engage the stabilizing bracket with the tibial trial structure, and blocking the support platform, to prevent rotation relative to the stabilizer arm. The method further includes placing the tibial prosthesis component on the support platform after removing the tibial trial structure so that the third axis formed by the distal nail of the tibial prosthesis component is in a plane, and placing the tibial displacement adapter on the distal nail. The tibial offset adapter includes a distal end that forms a fourth axis offset from the third axis. The method includes turning the distal end of the tibial offset adapter to position the fourth axis in a vertically passing plane and attaching the tibial offset adapter to the tibial prosthesis component, while the third axis and the fourth axis are located in the plane.

[0033] In some embodiments, the implementation of the method may further include attaching the holder to the support platform. The step of placing the tibial trial construct on the support platform may include placing the tibial trial construct on the holder and extending the first clamp bar of the holder into engagement with the trial base of the tibial trial construct to secure the trial base between the first clamp bar and the second clamp bar of the holder.

[0034] In addition, in some embodiments, the step of placing the tibial prosthesis component on the support platform after removing the tibial trial construct may include placing the tibial prosthesis component on the holder and extending the first clamp bar into engagement with the tibial prosthesis component to secure the tibial prosthesis component between the first clamp bar and a second clamping bar.

[0035] In some embodiments, the method may further include attaching a nail component to the distal end of the tibial bias adapter. The method may also include extending the stabilizing arm along the vertically extending plane to engage the stabilizing arm with the distal end of the tibial offset adapter after rotating the distal end of the tibial offset adapter to position the third axis in the vertically extending plane.

[0036] In addition, in some embodiments, the step of extending the stabilizing arm along a vertically extending plane to engage the stabilizing arm with the distal end of the tibial bias adapter may include placing the distal end of the tibial bias adapter in a channel formed in the proximal tip of the stabilizing arm.

[0037] In some embodiments, the step of extending the stabilizing arm along a vertically extending plane to engage the stabilizing arm with the trial bias adapter may include placing the trial bias component in a channel formed in the stabilizing arm.

[0038] In addition, in some embodiments, the method may further include attaching a trial bias adapter to the proximal tip of the stabilizing arm prior to locking the support platform to prevent rotation relative to the stabilizing arm.

[0039] In some embodiments, the method may further include aligning the visual marking of the trial bias adapter with an alignment window formed in the stabilizing bracket. In addition, in some embodiments, the step of extending the stabilizing arm along a vertically extending plane to engage the stabilizing arm with the bias trial adapter may further include aligning the beveled end surfaces of the proximal tip with the beveled or tapered surface of the bias trial component.

[0040] According to another aspect, a method for assembling an orthopedic prosthesis includes rotating the support platform of the surgical instrument about a vertically extending axis, attaching a holder to the support platform, and placing the first tibial prosthesis component on the holder. The first tibial component of the prosthesis includes a tibial groove and a pin extending from the tibial groove. The method further includes extending the first retainer latch into engagement with the tibial trough to attach the tibial trough between the first retainer latch and the second holder latch and attaching the second tibial prosthesis component to the first tibial prosthesis component shaft.

[0041] In some embodiments, the step of attaching the second tibial prosthesis component to the shaft of the first tibial prosthesis component may include sliding the second tibial prosthesis component along the tapering outer surface of the shaft to secure the second tibial prosthesis component to the shaft. The second tibial prosthesis component may include a stepped outer surface.

[0042] In some embodiments, the step of attaching the second tibial prosthesis component to the shaft of the first tibial prosthesis component may further comprise connecting the first end of the impactor to the distal end of the second tibial prosthesis component and applying force to the second end of the impactor.

[0043] In some embodiments, the method may further include selecting a tibial trial design, including a trial base and a tibial trial sleeve attached to the trial base, and including a stepped outer surface corresponding to a stepped outer surface of the second tibial prosthesis component, and rotating the second tibial prosthesis component on the pin of the first tibial prosthesis component to orient the second tibial prosthesis component based on the orientation on the trial sleeve relative to the trial base.

[0044] In some embodiments, the pin of the first tibial prosthesis component may form the first axis, and the step of attaching the second tibial prosthesis component to the pin of the first tibial prosthesis component may include rotating the distal end of the second tibial prosthesis component to position the second axis formed by the distal end into a vertically passing plane, and attaching the second tibial prosthesis component to the pin of the first tibial prosthesis component, wherein the first axis and the second axis are located in a vertically passing plane.

[0045] In some embodiments, the method may further include extending the surgical instrument stabilizing arm along a vertical plane to position the stabilizing arm over the distal end of the second tibial prosthesis component, and attaching the second tibial prosthesis component to the stabilizing arm. The stabilizing arm may have an elongated body which extends along a vertically extending plane.

[0046] In addition, in some embodiments, the step of extending the stabilizing arm along a vertically extending plane to position the stabilizing arm over the distal end of the second tibial prosthesis component may include placing the distal end of the second tibial prosthesis component in a channel formed in the proximal tip of the stabilizing arm.

[0047] In some embodiments, the implementation of the method may further include the installation of the tibial trial design on the holder. The tibial trial design may include a trial base that forms a base axis and a displacement trial component that forms a shaft axis that is offset from the base axis. The method may include extending the stabilizing bracket of the surgical instrument along a passing vertical plane to engage the stabilizing bracket with the tibial trial structure, blocking the support platform to prevent rotation relative to the stabilizing bracket, and removing the tibial trial structure from the holder before placing the first tibial prosthesis component on the holder. The step of rotating the support platform of the surgical instrument may include rotating the holder and the tibial trial structure to bring the base axis and shaft axis into a vertically extending plane.

[0048] According to another aspect, a method for assembling an orthopedic prosthesis includes aligning a trial prosthesis assembly with a surgical instrument that includes a support platform and a stabilizing arm. The trial prosthesis assembly includes a trial prosthesis component that forms a first axis and a trial offset adapter that forms a second axis offset from the first axis. The method also includes placing the test prosthesis assembly on the support platform, rotating the support platform to transfer the first axis and the second axis to a plane passing vertically through the stabilizing bracket, extending the stabilizing bracket along the vertically passing plane to engage the stabilizing bracket with the trial prosthesis assembly, blocking the support platform, to prevent rotation with respect to the stabilizing arm, and positioning the prosthesis component on the support platform after removing the trial prosthesis assembly so that the third axis formed by the pin of the prosthesis component is in a plane. The prosthesis component is sized and shaped to match the size and shape of the trial prosthesis component. The method additionally includes mounting a bias adapter on a pin, which includes an end forming a fourth axis offset relative to the third axis by an amount equal to the offset of the first axis and the second axis, turning the end of the bias adapter to transfer the fourth axis to a vertically passing plane, fastening the bias adapter on the prosthesis component, while the third axis and the fourth axis are located in the plane.

[0049] In some embodiments, the prosthesis component is a tibial prosthesis component and the prosthetic trial component is a tibial trial component. In some embodiments, the prosthesis component is a femoral prosthesis component and the prosthetic trial component is a femoral trial component.

[0050] According to another aspect of the description, a method for assembling an orthopedic prosthesis includes aligning a femoral trial construct with a surgical instrument that includes a support platform and a stabilizing arm. The femoral trial construct includes a pin that forms a first axis and an offset trial adapter that forms a second axis offset from the first axis. The method also includes placing the femoral trial structure on the support platform, rotating the support platform to transfer the first axis and the second axis to a plane passing vertically through the stabilizing bracket, extending the stabilizing bracket along the vertically passing plane to engage the stabilizing bracket with the femoral trial structure, and blocking the support platform, to prevent rotation relative to the stabilizer arm. The method further includes placing the femoral prosthesis component on the support platform after removing the femoral trial structure so that the third axis formed by the proximal nail of the femoral prosthesis component is in a plane, placing the femoral bias adapter on the proximal nail, wherein the femoral bias adapter includes a proximal end , which forms a fourth axis offset relative to the third axis, and rotation of the proximal end of the femoral offset adapter to translate the fourth axis into a vertically extending plane. The method includes attaching a femoral displacement adapter to a femoral component of the prosthesis, with the third axis and the fourth axis located in a plane.

[0051] In some embodiments, the implementation of the method may include attaching the holder to the support platform. The holder may include a support bar and a pin extending upwardly from the support bar. The step of placing the femoral trial on the support platform may include extending the femoral trial on top of the pin to place the pin in the passage formed in the femoral trial.

[0052] In addition, in some embodiments, the implementation of the method may further include the connection of the holder with a gasket, the size of which allows installation in the intercondylar slot formed in the femoral trial design. The step of placing the femoral trial construct on the support platform may further include advancing the femoral trial construct over the pad to place the pad in the intercondylar slit, and placing the femoral trial construct on the support platform may include preventing a pair of condyles of the femoral trial construct from engaging with the carrier support bar.

[0053] In some embodiments, the implementation of the method may further include detaching the holder from the support platform and attaching the second holder to the support platform. The second holder may include a second support bar and a second pin extending upwardly from the second support bar. The second pin may have a configuration that is different from that of the first pin. The method may also include attaching the spacer to the second holder.

[0054] In addition, in some embodiments, the step of placing the femoral prosthesis component on the support platform after removing the femoral trial construct may include extending the femoral prosthesis component over the second pin to accommodate the second pin in the passage formed in the femoral prosthesis component, extending the femoral prosthesis component over spacers for accommodating the spacer in the intercondylar slot of the femoral prosthesis component; and preventing engagement of the pair of condylar surfaces of the femoral prosthesis component with the second support platform of the second holder.

[0055] In some embodiments, the method may include determining whether the femoral trial construct includes one of a first femoral trial component configured to connect to the left hip or a second femoral trial component configured to connect to the right hip, and selecting a femoral component of the prosthesis, depending on whether the femoral trial construct includes a first femoral trial component or a second femoral trial component. The step of attaching the second holder to the support platform may include orienting the second holder to the support platform depending on the selected femoral component of the prosthesis, and connecting the pad to the second holder may include connecting the pad to one of the first wall of the second holder located on the first side of the second pin, or the second wall of the second holder, located on the second side of the second pin, depending on the selected femoral component of the prosthesis.

[0056] In some embodiments, the step of placing the femoral prosthesis component on the abutment platform may include orienting the prosthesis femoral component such that the third axis is at an orthogonal angle with respect to the abutment platform. The femoral component of the prosthesis may include a pair of condyles and a box structure that connects the pair of condyles. The box structure may include a planar proximal surface that extends at a non-orthogonal angle with respect to the third axis.

[0057] In some embodiments, the method may further include attaching the shaft component to the proximal end of the femoral bias adapter. In some embodiments, the method may further include extending the stabilizing arm along the vertically extending plane to engage the stabilizing arm with the proximal end of the femoral offset adapter after rotating the proximal end of the femoral offset adapter to position the third axis in the vertically extending plane.

[0058] In addition, in some embodiments, the step of extending the stabilizing arm along a vertically extending plane to engage the stabilizing arm with the proximal end of the femoral bias adapter includes positioning the proximal end of the femoral bias adapter in a channel formed between a pair of proximal tips of the stabilizing arm. In some embodiments, the step of extending the stabilizing arm along a vertically extending plane to engage the stabilizing arm with the trial bias adapter comprises placing the trial bias component in a channel formed in the stabilizing arm.

[0059] In some embodiments, the method may further include attaching a trial bias adapter to the proximal tip of the stabilizing arm prior to locking the support platform to prevent rotation relative to the stabilizing arm. In addition, in some embodiments, the method may further include aligning the visual marking of the trial bias adapter with an alignment window formed in the stabilizing bracket.

[0060] In some embodiments, the step of extending the stabilizing arm along a vertically extending plane to engage the stabilizing arm with the bias trial adapter may further include aligning the pair of beveled end surfaces of the proximal tip with the beveled surface of the bias trial component.

[0061] According to another aspect, a method for assembling an orthopedic prosthesis includes rotating the support platform of the surgical instrument about a vertically extending axis, attaching the holder to the support platform, connecting the pad to the holder, and placing the first femoral component of the prosthesis on the holder. The first femoral component of the prosthesis includes a pair of spaced apart condyles, an intercondylar slot sized to accommodate a pad, and a proximal nail. The method may also include attaching the second femoral prosthesis component to the proximal nail of the first femoral prosthesis component.

[0062] In some embodiments, the second femoral component of the prosthesis may include an elongated shaft component. In some embodiments, the implementation of the second femoral component of the prosthesis includes a prosthesis sleeve with a stepped outer surface.

[0063] The second femoral prosthesis component may include a bias adapter and an elongated shaft component configured to connect to the proximal end of the bias adapter. In some embodiments, the proximal shaft of the first femoral prosthesis component forms the first axis, and the step of attaching the second femoral prosthesis component to the shaft of the first femoral prosthesis component may include rotating the proximal end of the bias adapter to position the second axis formed by the proximal end in a vertically extending plane, and fastening the displacement adapter to the proximal pin of the first femoral component of the prosthesis, wherein the first axis and the second axis are located in a vertically passing plane.

[0064] In some embodiments, the method may further include extending the surgical instrument stabilizing arm along a vertical plane to position the stabilizing arm over the proximal end of the bias adapter, and attaching the bias adapter to the stabilizing arm.

[0065] According to another aspect, a surgical instrument system for assembling an orthopedic prosthesis for a patient's knee includes a prosthesis component holder configured to receive an orthopedic prosthesis component. In some embodiments, the prosthesis component holder may include a support block and a post extending at a non-orthogonal angle relative to the support block. The nail may include a distal end sized to accommodate the passage of the femoral component of the prosthesis.

[0066] In some embodiments, the prosthesis component holder may include a first clamp bar and a second clamp bar that are movable to grip a tibial prosthesis component between the first clamp bar and the second clamp bar.

[0067] In some embodiments, the surgical instrument system may further include an open-ended wrench sized to accommodate a femoral sleeve configured to couple to a femoral prosthesis component. The open mouth may be formed by a plurality of key surfaces. The key may also include a plurality of protrusions extending from the surfaces into the open throat. Each protrusion may be shaped to grip the surface of the femoral sleeve.

[0068] According to another aspect, a surgical instrument system for assembling an orthopedic prosthesis for a patient's knee includes a trial component holder configured to receive a trial component that corresponds to an orthopedic prosthesis component. In some embodiments, the trial component holder may include a support block and a pin extending at a non-orthogonal angle relative to the support block. The nail may include a distal end sized to accommodate a femoral trial component corresponding to the femoral component of the prosthesis in the passage.

[0069] In some embodiments, the probe holder may include a first grip and a second grip that are movable to grip the tibial probe between the first grip and the second grip.

BRIEF DESCRIPTION OF GRAPHICS

[0070] The detailed description refers in particular to the following figures, wherein:

[0071] in FIG. 1 is an exploded perspective view of the components of an orthopedic surgical instrument system for assembling an implantable orthopedic prosthesis;

[0072] in FIG. 2 is an exploded perspective view of the instrument assembly base for the orthopedic surgical instrument system of FIG. one;

[0073] in FIG. 3 is a bottom plan view showing the rotation locking mechanism of the base for assembling the tool shown in FIG. 2, in the unlocked position;

[0074] in FIG. 4 is a view similar to FIG. 3 with the pivot lock mechanism shown in the locked position;

[0075] in FIG. 5 is an exploded perspective view of the stabilizing arm for the orthopedic surgical instrument system shown in FIG. one;

[0076] in FIG. 6 is a perspective view of the femoral trial prosthesis holder and pad of the orthopedic surgical instrument system shown in FIG. one;

[0077] in FIG. 7 is a side elevational view of the prosthetic femoral trial holder shown in FIG. 6;

[0078] in FIG. 8 is a perspective view of the femoral component holder of the orthopedic surgical instrument system shown in FIG. one;

[0079] in FIG. 9 is a side elevational view of the femoral component holder of the prosthesis shown in FIG. eight;

[0080] in FIG. 10 is a perspective view of the tibial component holder of the orthopedic surgical instrument system shown in FIG. one;

[0081] in FIG. 11 is a cross-sectional elevational view of the tibial component holder taken along line 11-11 in FIG. ten;

[0082] in FIG. 12 is an exploded perspective view of the components of a femoral prosthesis system;

[0083] in FIG. 13 is a perspective view of a femoral sleeve component on a femoral prosthesis component;

[0084] in FIG. 14 is an exploded perspective view of a femoral trial construct for use in testing the femoral prosthesis system shown in FIG. 12;

[0085] in FIG. 15 is a perspective view of a thigh drill;

[0086] in FIG. 16 is an exploded perspective view of the components of a tibial prosthesis system;

[0087] in FIG. 17 is an exploded perspective view of a tibial trial construct for use in testing the tibial prosthesis system shown in FIG. 16;

[0088] in FIG. 18 is a perspective view of the sleeve impactor of the system shown in FIG. one;

[0089] in FIG. 19 is a side elevational view of the sleeve impactor shown in FIG. eighteen;

[0090] in FIG. 20 is a side elevational view from the opposite side of FIG. 19; and

[0091] in FIG. 21-47 show examples of assembly techniques for various orthopedic prostheses using the tool system shown in FIG. one.

DETAILED DESCRIPTION OF GRAPHICS

[0092] Although the concepts of the present disclosure may be subject to various modifications and may take alternative forms, the drawings exemplify their specific embodiments, which will be described in detail herein. However, it should be understood that the concepts of the present disclosure are not limited to the specific forms described, but rather, they are intended to cover all modifications, equivalents, and alternatives within the spirit and scope of the invention as defined in the appended claims.

[0093] Anatomy spatial orientation terms such as "anterior", "posterior", "medial", "lateral", "superior", "inferior", etc., may be used herein to refer to orthopedic implants or prostheses and surgical instruments described in this document, as well as in relation to the natural anatomy of the patient. The meanings of such terms are well understood both in scientific anatomy and in the field of orthopedics. It is assumed that the use of such anatomical terms of spatial orientation in the text description and the claims is consistent with their understandable meanings, unless otherwise indicated.

[0094] FIG. 1 shows an orthopedic surgical instrument system 10 for use in the selection and assembly of an orthopedic prosthesis. The surgical instrument system 10 includes an instrument base 12 and a series of modular instruments 14 that are selectively coupled to the base to place a femoral prosthesis component 16 (see FIG. 12) or a tibial prosthesis component 18 (see FIG. 19) on base 12 As described in more detail below, some of the tools 14 can be used to place a femoral trial piece 20 (see FIG. 14) or a tibial trial piece 22 (see FIG. 20) on base 12 to assist the surgeon in assembling the prosthesis components. In an exemplary embodiment, the instrument system 10, prosthesis components 16, 18, and trial components 20, 22 form part of an orthopedic system that can be used to replace a patient's knee joint. While only one size of each prosthesis component and each trial component is given in this example, it should be understood that an orthopedic system may include multiple sizes of prosthesis components and trial components to meet the needs of different patients.

[0095] The modular instruments 14 of the system 10 include a femoral trial prosthesis holder 30 that is configured to mount a femoral trial component 20 on the instrument base 12. The instruments 14 also include a femoral prosthesis component holder 32 which is configured to mount the femoral prosthesis component 16 on the instrument base 12 and a tibial prosthesis component holder 34 which in an exemplary embodiment is configured to mount either a tibial prosthesis component 18 or a tibial prosthesis component 18. of the trial component 22 on the base 12. Each of the holders 30, 32, 34 is sized to accommodate any size prosthesis component or trial orthotic component, as described in more detail below. As shown in FIG. 1, modular instruments 14 also include a stabilizing or support arm assembly 36 that can be used with holders 30, 32, 34 during the assembly of a prosthesis.

[0096] The instrument base 12 includes a body 40 configured to be placed on a flat surface such as, for example, an operating room table. The tool base 12 includes a platform 42 that is rotatable relative to the body 40 about an axis 38. The platform 42 includes a pair of studs 44 sized to selectively position each of the holders 30, 32, 34 to orient the holders 30, 32, 34 based on 12 tool.

[0097] As shown in FIG. 1, platform 42 is located in central section 46 of housing 40. Housing 40 also includes an elongate plate 48 that extends outward from central section 46 and an end plate 50 that opposes elongated plate 48. Support pin 52 extends upward from end 54 of elongate plate 48 and is configured to accommodate the node 36 of the support bracket. The tool base 12 also includes a locking mechanism 56 that is located on the end plate 50. As described in more detail below, the locking mechanism 56 can be used to lock the platform 42 in a specific orientation about the axis 38 relative to the body 40.

[0098] As shown in FIG. 2, the body 40 includes a flat top surface 60 and the central section 46 of the tool base 12 includes a cavity 62 formed on the top surface 60 sized to accommodate a platform 42. The tool base 12 includes a frame 64 located at the bottom of the cavity 62 , which provides support for the platform 42. The platform 42 is secured to the body 40 by a retaining plug 66 that extends through a central hole 68 formed in the platform 42 and engages with a support pin 70 that extends upward from the frame 64 at the center of the cavity 62.

[0099] In an exemplary embodiment, plug 66 includes a top plate 72 and a shaft 74 that extends downward from top plate 72. Shaft 74 is sized to fit into hole 76 formed in mounting pin 70 for attaching plug 66 to housing 40. As shown in FIG. 2, platform 42 includes disc 80 which has a flat top surface 82 and a central hole 68 extends through top surface 82 to bottom surface 84 of disc 80. Rim wall 88 extending into center hole 68 engages top plate 72. plugs 66 to hold platform 42 between top plate 72 and frame 64 of body 40. In the exemplary embodiment, tool base 12 also includes an annular washer 90 that is placed between rim wall 88 and mounting pin 70, acting as an insert between the fixed pin 70 and turntable 42. As shown in FIG. 2, the axis 38 around which the platform 42 rotates passes through the center of the central hole 68.

[0100] Disc 80 includes an outer annular wall 100 extending from top surface 82 to bottom surface 84. Disc 80 also includes a plurality of gear teeth 102 that are formed in outer wall 100 around the circumference of disc 80. As described in more detail below , the teeth 102 of the gear co-operate with the locking mechanism 56 to lock the support platform 42 in position relative to the housing 40. The support platform 42, plug 66 and annular washer 90, like the housing 40, are made of materials that can be autoclaved, such as e.g. stainless steel.

[0101] As described above, the support platform 42 also includes a pair of studs 44 sized to selectively place each of the holders 30, 32, 34 to orient the holders 30, 32, 34 on the tool base 12. In an exemplary embodiment, studs 44 extend upward from top surface 82 of disc 80. Studs 44 include a substantially cylindrical stud 104 that is located on one side of opening 68 and a polygonal stud 106 that is located on the opposite side of opening 68. Polygonal stud 106 has a width that is less than the diameter of the cylindrical stud 104. It should be understood that in other embodiments, the studs may have different geometries and may have different sizes to orient the holders.

[0102] The platform 42 includes visual indicators 110 and the housing 40 includes visual indicators 112 that can be used during a surgical operation to verify proper orientation and position of the instruments. In an exemplary embodiment, indicators 110 on platform 42 include arrows and letters (L stands for "Left" and R stands for "Right"). The indicators 112 on the body 40 include indicator lines, and the indicator arrows 110 may align with the indicator lines to indicate the orientation and position of the tools. In other embodiments, indicators 110, 112 may include numbers or other indicators.

[0103] As described above, tool base 12 also includes a support pin 52 that extends upward from end 54 of elongate plate 48. Support pin 52 is configured to receive support bracket assembly 36. In an exemplary embodiment, pin 52 includes a top end 120 and a hole 122 that is formed at top end 120. A central channel 124 sized to accommodate a support shaft 126 of support bracket assembly 36 extends inwardly from hole 122. Pin 52 also includes a mounting slot 128 that extends from the upper end 120 and exits into the passage 124. The mounting slot 128 is sized to fit into the mounting tab 130 of the support bracket assembly 36 and forms a curved path for the mounting tab 130 that forces the support bracket assembly 36 rotate from the initial insertion position to the final assembly position relative to the platform 42. In the final assembly position, the mounting tab 130 is held in the lower recess 132 of the mounting slot 128.

[0104] As described above, the tool base 12 also includes a locking rotation mechanism 56 that is located on the end plate 50. Each of the components of the mechanism 56 is formed from a material such as, for example, stainless steel, which can be autoclaved, so that base 12 can be sterilized between surgeries. The locking mechanism 56 includes a user-operated handle 140 that fits into a cavity 142 formed in the outer surface 60 of the base body 40. The handle 140 is rotatable relative to the base body 40 and includes a main plate 144 and an elongated grip 146 that extends upward from the main plate 144. In an exemplary embodiment, the elongated grip 146 includes a pointed tip 148 that indicates whether the handle is 140 in the locked position or in the unlocked position. The pointed tip 148 may be directed towards the indicators on the body 40 to indicate a locked or unlocked position. The handle 140 also includes an elongated base 152 that extends downward from the main plate 144 and is received in the cavity 142.

[0105] In an exemplary embodiment, the body base 40 includes a frame 154 that sits on the bottom of the cavity 142, providing support for the base 152 of the handle 140. The handle 140 is connected to the body base 40 by a fastener 156 that extends through the frame 154. member 156 extends through cylindrical mounting pin 158 and engages in elongate base 152 of handle 140. As shown in FIG. 3, the fastener 156 is located in a hole 160 that is offset from the center of the elongated base 152. The hole 160 defines the axis of rotation 166 of the handle 140. The elongated base 152 also includes an arcuate channel or groove 162 that receives a guide pin 164 attached to the frame. 154. Pin 164 engages groove 162 to limit pivotal movement of handle 140, as described in more detail below.

[0106] As also shown in FIG. 2, locking mechanism 56 also includes a cam 170 that selectively engages teeth 102 of platform gear 42. Cam 170 includes a mounting housing 172 and a pair of arms 174, 176 that extend outward from the mounting housing 172. In an exemplary embodiment, The central hole 178 extends through the locating body 172 and is sized to accommodate the shaft 180 of the locating pin 182. The shaft 180 includes a threaded distal end 184 that engages in a threaded engagement with a hole 186 formed in the base body 40 for attaching the locating pin 182. 182 to the housing 40. The mounting housing 172 is held between the top plate 188 of the mounting pin 182 and the inner surface 190 of the housing 40. The central hole 178 forms the axis of rotation 192 of the Cam 170.

[0107] Branch 174 of cam 170 extends from mounting body 172 to tip 200. Tip 200 includes a plurality of teeth 202 sized and shaped to mesh with teeth 102 of platform gear 42. As shown in FIG. 2, an elongated opening 204 is formed between frame 154 and inner surface 190 of housing 40. Tip 200 passes through opening 204 to engage gear teeth 102 as cam 170 rotates about axis 192.

[0108] Another branch 176 of the cam 170 extends from the mounting housing 172 to a follower housing 210 sized to fit between the frame 154 and the base plate 144 of the handle 140. The follower housing 210 includes an upper opening 212 and an inner wall 214 that extends inward from opening 212 to form an elongated slot 216 sized to receive an elongated base 152 of the handle 140. As shown in FIG. 3, the elongated slot 216 is larger than the elongated base 152. The inner wall 214 of the follower body 210 includes a follower surface 220, and the elongated base 152 includes a cam surface 222 configured to selectively engage with the follower surface 220 to rotate the cam 170. around the axis 192.

[0109] To lock the platform 42 in any orientation relative to the base body 40, the surgeon or other user may hold the grip 146 of the handle 140 and rotate the handle 140 in the direction indicated by arrow 224 in FIG. 3. As the handle 140 is rotated, the section 226 of the cam surface 222 of the elongate base 152 that was not initially in contact with the surface of the follower 220 engages with the surface of the follower 220. As the section 226 of the cam surface 222 engages with the surface of the follower element 220, the cam 170 rotates about the axis 192, as indicated by arrow 232, to bring the teeth 202 into engagement with the teeth 102 of the platform 42, thereby locking the platform 42 in position relative to the housing 40. As shown in FIG. 4, the guide pin 164 moves from one end of the groove 162 to the opposite end of the groove 162 and prevents further rotation of the handle 140 (and hence the cam 170).

[0110] To unlock the platform 42, the surgeon or other user may hold the grip 146 of the handle 140 and rotate the handle 140 in the direction indicated by arrow 228 in FIG. 4. As the handle 140 is rotated, the section 230 of the cam surface 222 of the elongated base 152 that has not been in contact with the surface of the follower 220 engages with the surface of the follower 220. As the section 230 of the cam surface 222 engages with the surface 220 of the follower element, the cam 170 rotates about the axis 192 as indicated by arrow 234 to disengage the teeth 202 from the teeth 102 of the platform 42.

[0111] As also shown in FIG. 1, system 10 also includes a support bracket assembly 36 that is mountable to tool base 12. The support bracket assembly 36 includes a support shaft 126 extending from a lower end 250 sized to fit into the support pin 52 to an upper end 252. The bracket 254 is attached to the upper end 252 and such bracket 254 includes a central passage 256, the dimensions of which provide the placement of an elongated handle 258 node 36 of the support bracket. An elongated handle 258 extends along longitudinal axis 260 from handle end 262 to tip 264. As described in more detail below, elongate handle 258 is slidable within passage 256 along axis 260 to extend tip 264 toward axis 38 of tool base 12 and away from her. In addition, the longitudinal axis 260 and the axis 38 are located in (and form) a vertically extending orientation plane 270 (see FIG. 21), which is described in more detail below.

[0112] As shown in FIG. 5, the elongate handle 258 includes a main body 272 that extends from the end 262 of the handle. In an exemplary embodiment, grip grip 274 is connected to main body 272 at handle end 262 via a pair of pins 276. Extended handle 258 also includes a pair of stems 278, 280 that extend from the end of main body 272 to tip 264 of extended handle 258. Stems 278 , 280 are spaced apart so that a channel 282 is formed therebetween. The channel 282 is wider at its proximal end 288 at the tip 264 and narrower near the elongated handle 258. As described in more detail below, the channel 282 is sized to accommodate knot offset adapters trial component and components of the prosthesis component.

[0113] Each shaft 278, 280 includes a beveled end wall 284 that forms the tip 264 of the elongated handle 258 and an inner wall 286 that faces the other shaft. The inner walls 286 of the shafts 278, 280 together form the proximal end 288 of the channel 282.

[0114] In an exemplary embodiment, the support arm assembly 36 includes a tension mechanism 300 that can be actuated to narrow the proximal end 288 of the channel 282 by bringing the shafts 278, 280 together. The tension mechanism 300 includes a user-operated handle 302 and an elongate shaft 304 extending from the handle 302. The elongate shaft 304 extends through a hole (not shown) formed in the shaft 280 to a threaded end 306 that is received in a threaded hole 308 formed in barrel 278.

[0115] As shown in FIG. 5, the bracket 252 of the support bracket assembly 36 includes a top housing 310 and a stem 312 that extends from the top casing 310. The stem 312 is sized to accommodate a passageway 314 formed in the support shaft 126. In an exemplary embodiment, the shaft 312 is attached to the shaft 126. through a pin 316. The upper body 310 includes a central passage 256 through which extends an elongated handle 258. It will be understood that each of the components of the support arm assembly 36 is formed from a material such as, for example, stainless steel, which can be autoclaved, so that the support arm assembly 36 can be sterilized between surgeries.

[0116] As also shown in FIG. 1, the system 10 also includes a femoral trial prosthesis holder 30, a femoral prosthesis component holder 32, and a tibial component holder 34 that are selectively mounted on the platform 42 of the instrument base 12. In other words, each of the holders 30, 32, 34 is configured to be mounted on the platform 42 in place of any other of the holders 30, 32, 34. Each of the holders 30, 32, 34 includes a pair of orientation holes 320, 322, the dimensions of which provide placement of studs 104, 106 respectively of platform 42 to orient and secure holders 30, 32, 34 to platform 42. In the exemplary embodiment, each orientation hole 320, 322 has a cylindrical profile, but orientation hole 320 has a larger diameter compared to orientation hole 322, so that the holders 30, 32, 34 are designed to be mounted on the platform 42 in only one orientation. It should be understood that each of the holders 30, 32, 34 is formed from a material such as, for example, stainless steel, which can be autoclaved, so that the holders 30, 32, 34 can be sterilized between surgical procedures.

[0117] As shown in FIG. 6, the femoral trial prosthesis holder 30 includes a support block 330 and a pin 332 that extends upwardly from the support block 330. The support block 330 is elongated and extends along a longitudinal axis 334 from a longitudinal end 336 to its opposite longitudinal end 338. Block 330 includes a flat bottom surface 340 and a top surface 342 that is opposite bottom surface 340. Outer wall 344 connects top surface 342 to bottom surface 340. In an exemplary embodiment, visual indicators 346 are applied to outer wall 344 at each of ends 336, 338 to indicate the orientation of the support block 330. The visual indicators 346 in the exemplary embodiment include letters ("Left" at the end 336 and "Right" at the end 338).

[0118] Pin 332 extends from top surface 342 of block 330 to top end 348. In an exemplary embodiment, pin 332 includes a cylindrical outer surface 350 and a locating pin 352 extends upward from top end 348. The locating pin 352 is shaped to fit into hole 732 ( see FIG.23) of the femoral trial component 20. As shown in FIG. 6-7, the locating pin 352 includes a rounded base 354 and extends to a narrow tip 356. The pin 332 extends along a longitudinal axis 360 passing through the tip 356. The axis 360 (and hence the pin 332) extends at an orthogonal angle relative to the top surface. 342 block 330.

[0119] The femoral trial prosthesis holder 30 also includes a pair of walls 362, 364 extending upward from the top surface 342 of the block 330 on opposite sides of the shaft 332. In an exemplary embodiment, the walls 362, 364 extend at a non-orthogonal angle relative to the top surface 342. Each wall 362, 364 connects to pin 332 and includes flat outer surfaces 366, 368 that extend to ends 336, 338 of holder 30. A rib 370 is formed on outer surface 366 of each of walls 362, 364. As shown in FIG. 6, the ribs 370 run parallel to the longitudinal axis 334.

[0120] As described above, holder 30 includes a pair of orienting holes 320, 322 sized to accommodate pins 104, 106 respectively of platform 42 to orient and secure holder 30 to platform 42. In an exemplary embodiment, holes 320, 322 extend through block 330 and include top outlets located in a channel 372 formed on top surface 342 proximate walls 362, 364.

[0121] As shown in FIG. 8, a femoral prosthesis holder 32 includes a support block 430 and a pin 432 that extends upwardly from the support block 430. The support block 430 is elongated and extends along a longitudinal axis 434 from a longitudinal end 436 to its opposite longitudinal end 438. Block 430 includes a flat bottom surface 440 and a top surface 442 that is opposite bottom surface 440. Outer wall 444 connects top surface 442 to bottom surface 440. In an exemplary embodiment, visual indicators 446 are applied to outer wall 444 at each of ends 436, 438 to indicate the orientation of the support block 430. The visual indicators 446 in the exemplary embodiment include letters ("Left" at the end 436 and "Right" at the end 438).

[0122] Pin 432 extends from top surface 442 of block 430 to top end 448. In an exemplary embodiment, pin 432 includes a cylindrical outer surface 450. Pin 432 extends along longitudinal axis 460, and top end 448 is sized to accommodate hole 622 ( see Fig. 31) of the femoral component 16 of the prosthesis. In an exemplary embodiment, pin 432 extends at a non-orthogonal angle relative to top surface 442 of block 430, as shown in FIG. 9.

[0123] The holder 32 of the femoral component also includes a pair of walls 462, 464 extending upward from the top surface 442 of the block 430 on opposite sides of the pin 432. In the exemplary embodiment, the walls 462, 464 extend parallel to the pin 432. Each wall 462, 464 connects with a pin 432 and includes flat outer surfaces 466, 468 that extend to the ends 436, 438 of the holder 32. A rib 470 is formed on the outer surface 466 of each of the walls 462, 464. As shown in FIG. 8, the ribs 470 run parallel to the longitudinal axis 434.

[0124] As described above, holder 32 includes a pair of orienting holes 320, 322 sized to accommodate pins 104, 106 respectively of platform 42 to orient and secure holder 32 to platform 42. In an exemplary embodiment, holes 320, 322 extend through block 430 and include top outlets located in a channel 472 formed on top surface 442 proximate walls 462, 464.

[0125] As shown in FIG. 8, walls 462, 464 include relief slots 474 extending through surfaces 466, 468 adjacent pin 432. Also, as shown in FIG. 9, the top surface 442 of the block 430 includes a section 476 opposite the rib 470 that extends from the inner edge 478 to the outer edge 480. The section 476 extends at a non-orthogonal angle with respect to the bottom surface 440 such that the outer edge 480 is closer to the bottom surface. 440 than inner edge 478.

[0126] As shown in FIG. 10, system 10 also includes a tibial component holder 34. As described above, the holder 34 is configured to secure either the tibial prosthesis component 18 or the tibial trial component 22 to the base 12. The holder 34 includes a support block 500 and a pair of clamp bars 502, 504 movably attached to the support block 500. As described in more detail below, the holder 34 also includes a screw drive mechanism 506 configured to move the clamp bars 502, 504 to grip the tibial prosthesis component 18 or tibial trial component 22 mounted on the plates 502, 504.

[0127] The base block 500 includes a base plate 510 and a pair of side walls 512 that extend upward from the base plate 510. Each side wall 512 includes a flat top surface 514. A channel 516 through the support block 500 is formed between the base plate 510 and the side walls 512. As shown in FIG. 10, a flange 518 extends inwardly from each side wall 512 into the channel 516 to provide support for the clamping bars 502, 504.

[0128] The clamp bar 502 of the holder 34 includes an upper body 530 located above the side walls 512 and a lower body 532 extending downward from the upper body 530. The lower body 532 is received in a channel 516 and a pair of legs 534 extends outward from the lower body 532 to engage the bottom surfaces of the flanges 518 of the support block 500. As shown in FIG. 10, the flanges 518 are located in the channels 536 formed between the legs 534 and the flat bottom surface 538 of the upper body 530. The upper body 530 also includes a top surface 540 that is opposite the bottom surface 538.

[0129] The clamp bar 502 includes a jaw 542 extending upward from the upper surface 540. The jaw 542 has a curved inner wall 544 that is shaped to match the curvature of the anterior wall section 934 of the tibial prosthesis component 18 and the tibial trial component 22. The jaw 542 also includes an engaging tongue 546 extending outwardly from the curved inner wall 544.

[0130] As described above, the holder 34 also includes a clamp bar 504 located opposite the clamp bar 502. The clamp bar 504 includes an upper housing 550 located above the side walls 512 and a lower housing 532 extending downward from the upper housing 550 The lower body 532 has a configuration that is identical in relevant aspects to the lower body 532 of the clamp bar 502. The lower body 532 of the clamp bar 504 is received in the channel 516 and a pair of legs 534 extend outwardly from the lower case 532 to engage the bottom surfaces of the flanges 518 of the support block 500 .

[0131] The upper body 550 of the clamp bar 504 includes an upper surface 552 that is opposite the lower surface 554. The clamp bar 504 includes a pair of tabs 556, 558 extending upward from the upper surface 552. As shown in FIG. 10, a Y-shaped channel 560 is formed between the tabs 556, 558. The clamping bar 504 also includes a jaw 562 extending upward from the top surface 552. The jaw 562 includes a pair of curved, concave inner walls 564 and a curved, convex inner wall 566 that located between the walls 564. The shape of the walls 564, 566 matches the curvature of the posterior wall sections 936, 938 of the tibial prosthesis component 18 and the tibial trial component 22. The jaw 562 also includes engaging tabs 568 extending outward from the curved inner walls 564.

[0132] As shown in FIG. 11, holder 34 includes a screw drive mechanism 506 configured to move clamp bars 502, 504. In an exemplary embodiment, mechanism 506 includes a threaded shaft 570 that engages in a threaded hole 572 formed in lower body 532 of clamp bar 502. The mechanism 506 includes a threaded shaft 574 that is received in a threaded hole 576 formed in the lower body 532 of the clamp bar 504. The mechanism 506 also includes a user operated handle 580 connected to the end of the threaded shaft 574.

[0133] The shafts 570, 574 are connected by a rod 582 that extends through the bracket 584 of the support block 500. As shown in FIG. 10-11, a bracket 584 extends from the side walls 512 of the support block 500 and is located in a channel 516. A pair of ring washers 590 extend from the stem 582 on each side of the bracket 584 to mount the mechanism 506 on the support block 500.

[0134] During the procedure, the surgeon or another user may grasp the handle 580 and rotate the shafts 570, 574. 574 clockwise, the clamping bars 502, 504 move towards each other; when the shafts 570, 574 are rotated counterclockwise, the clamp bars 502, 504 move in opposite directions.

[0135] As described above, the tool system 10 is configured for use in the selection and assembly of an orthopedic prosthesis. In an exemplary embodiment, the orthopedic prosthesis includes the femoral prosthesis component 16 shown in FIG. 12-13 and the tibial prosthesis component 18 shown in FIG. 16. Each of these components are part of larger prosthesis systems, which may include, for example, additional femoral and tibial prosthesis components of various sizes to suit the needs of patients with larger or smaller bones. The size and shape of the other components of the prosthesis may also be tailored to fit the patient's left limb or the patient's right limb. The systems may further include other prosthesis components that are connected to or used in conjunction with a femoral prosthesis component 16 and/or a tibial prosthesis component 18, as described in more detail below.

[0136] As shown in FIG. 12-13, the femoral prosthesis system 600 includes a femoral prosthesis component 16 configured to connect to a surgically prepared distal end of a patient's femur. The femoral component 16 includes an anterior flange 602 and a pair of condyles 604, 606 extending posteriorly from the anterior flange 602. An intercondylar slit 608 is formed between the pair of condyles 604, 606. In an example embodiment, the slit 608 is formed between a pair of sidewalls 610 that extend from the proximal surfaces 612 of the anterior flange 602 and the condyles 604, 606. The proximal wall 614 extends between the side walls 610 to seal the proximal end of the slot 608.

[0137] The femoral component 16 also includes a pin 616 that extends from the proximal wall 614. As shown in FIG. 12, the nail 616 includes a proximal opening 618 and an inner wall 620 extends inwardly from the proximal hole 618 to form an opening 622 passing through the nail 616 and the proximal wall 614 of the femoral component 16. In an exemplary embodiment, the inner wall 620 includes a threaded proximal section 624. Pin 616 also includes a tapered outer surface 626 sized to accommodate a metaphyseal component, such as, for example, a sleeve component 628 (see FIG. 13).

[0138] In an exemplary embodiment, the pin 616 extends along the longitudinal axis 630 and the proximal wall 614 of the femoral component 16 includes a substantially flat surface 632. When viewing the femoral component 16 in the frontal plane, a non-orthogonal angle formed between the axis 630 and the substantially flat surface 632. It should be understood that the magnitude of the angle may vary in different embodiments and depend on the size and configuration of the prosthesis assembly.

[0139] As shown in FIG. 12, the prosthesis system 600 also includes a shaft component 640. The shaft component 640 includes an elongated body 642 that extends from the distal end 644 to the proximal tip 646. The distal end 644 is formed by a plurality of threads 648 which, in some configurations of the prosthesis assembly, may engage the threaded proximal section 624 of the pin 616 or the threaded the proximal section 650 of the sleeve component 628 (see FIG. 13).

[0140] The prosthesis system 600 also includes an offset adapter 660 that is configured to attach to the femoral component 16 and the shaft component 640 to form an offset femoral prosthesis assembly 662. The offset adapter 660 includes a housing 664 that extends from a distal end 666 to a proximal end 668 offset from the distal end 666 as shown in FIG. 12. The body 664 includes a threaded shaft 670 that extends proximally from the distal end 666 to the rim wall 672. Housing 664 also includes a curved tapered surface 674 extending proximally from rim wall 672. The threaded shaft 670 is configured to engage with the threaded proximal section 624 of the pin 616 to secure the adapter 660 to the femoral component 16. The bias adapter 660 also includes a locking nut 676 threaded onto the shaft 670 that can be used to secure the bias adapter 660 to the femoral component. 16, as described in more detail below.

[0141] The body 664 also includes an opening 680 that is formed at the proximal end 668. A threaded inner wall 682 extends inwardly from the opening 680 to form a threaded opening 684 sized to accommodate the threaded distal end 644 of the shaft component 640. As shown in FIG. 12, the bias adapter 660 defines a proximal axis 686 that extends through the threaded hole 684 and along the longitudinal axis of the shaft component 640. The offset adapter 660 also defines a distal axis 688 that extends through the threaded shaft 670 and is aligned with the longitudinal axis 630 of the pin 616 of the femoral component 16. The axes 686, 688 are parallel but offset from each other. In an exemplary embodiment, housing 664 is a one-piece monolithic component such that distal end 666 and proximal end 668 are secured to each other.

[0142] As shown in FIG. 13, sleeve component 628 includes a stepped outer wall 690 that extends from distal end 692 to proximal end 694. Component 628 has opening 696 formed at proximal end 694 and an inner wall including a threaded proximal section 650 extending inwardly. from hole 696. Component 628 also has a distal hole (not shown) sized to accommodate pin 616. It should be understood that the distal hole is defined by a tapered inner surface that matches the tapered outer surface 626 of pin 616 so that sleeve component 628 can attach to pin 616 with a cone lock.

[0143] As shown in FIG. 13, the stepped outer wall 690 of the sleeve component 628 includes a porous section 700 configured to promote bone growth and reinforce fixation of the sleeve component 628 in the patient's bone. The outer wall 690 also includes a series of flat surfaces 702 at the proximal end 694 shaped to accommodate the key head 1264 (see FIG. 37) to simplify assembly, as described in more detail below. The stem component 640, the femoral component 16, and the sleeve component 628 form part of a femoral prosthesis sleeve assembly 704 that can be implanted in a patient's femur.

[0144] As shown in FIG. 14-15, the femoral probing system 710 includes a femoral probing component 20 that is configured to be temporarily connected to the distal end of a patient's femur to assist in surgical preparation of the patient's femur for placement of the prosthesis femoral component 16. The femoral trial component 20 includes an anterior flange 712 and a pair of condyles 714, 716 extending posteriorly from the anterior flange 712. Between the pair of condyles 714, 716, an intercondylar slit 718 is formed. 718 correspond to configurations of similar structures in the femoral component 16 of the prosthesis. It should be understood that in other embodiments, the femoral probing component may include one or more cutting guides that extend through the anterior flange 712 and/or condyles 714, 716.

[0145] In an exemplary embodiment, slot 718 is formed between a pair of side walls 720 that extend from proximal surfaces 722 of anterior flange 712 and condyles 714, 716. Proximal wall 724 extends between side walls 720 to seal the proximal end of slot 718. Femoral trial component 20 also includes a sleeve 726 extending from the proximal wall 724 that is configured to receive an offset adapter 770.

[0146] Sleeve 726 includes a flat proximal surface 728 and a pair of locating studs 730 extending outward from surface 728. Hole 732 extends through sleeve 726 and exits into intercondylar slot 718. Hole 732 is sized to allow a fastener, such as, for example, , bolt 734, pass through the femoral trial component 20 and connect to the bias adapter 770. In this way, the femoral trial component 20 and the bias adapter 770 can be connected to each other by means of the bolt 734.

[0147] In an exemplary embodiment, sleeve 726 extends along longitudinal axis 740 and proximal wall 724 of femoral component 16 includes a substantially flat surface 742. When viewing femoral component 16 in the frontal plane, a non-orthogonal angle formed between axis 740 and a substantially flat surface 742. It should be understood that the magnitude of the angle may vary in various embodiments and depend on the size and configuration of the prosthesis assembly.

[0148] As shown in FIG. 14, trial system 710 also includes a rod component 750. The stem component 750 includes an elongated body 752 that extends from a proximal tip 754 to a distal end 756. A plurality of threads 758 are formed at the distal end 756.

[0149] The trial system 710 also includes a bias adapter 770 that is configured to attach to the femoral trial component 20 and shaft component 750 to form a biased femoral trial structure 772. The bias adapter 770 includes a two-piece housing 774 that extends from the distal end 776 to a proximal end 778 offset from the distal end 776 as shown in FIG. 14. In an exemplary embodiment, the body 774 includes a distal sleeve 780 that extends from the distal end 776 to the proximal sleeve 782. The proximal sleeve 782 is rotatably coupled to the distal sleeve 780 to allow the surgeon to adjust the orientation of the femoral trial component 20 relative to the component 750. 662. The distal sleeve 780 includes a passageway 784 that extends inwardly from the distal end 776 to a threaded hole (not shown) in the proximal sleeve 782. The threaded hole is sized to accommodate the threaded end of bolt 734 for attaching adapter 770 to femoral trial component 20. As shown in FIG. 14, the proximal sleeve 782 also includes a curved tapering surface 786 that connects the wider base of the proximal sleeve 782 to the narrower proximal end 778.

[0150] The housing 774 also includes an opening 790 that is formed at the proximal end 778. A threaded inner wall 792 extends inwardly from the opening 790 to form a threaded opening 794 sized to accommodate the threaded distal end 756 of the shaft component 750. As shown in FIG. 14, the bias adapter 770 defines a proximal axis 796 that extends through the threaded hole 794 and along the longitudinal axis of the shaft component 750. The offset adapter 770 also defines a distal axis 798 that is aligned with the longitudinal axis 740 of the sleeve 726 of the femoral trial component 20. The axes 796, 798 run parallel to, but are offset from each other by the same amount as the axes 686, 688 in the prosthesis assembly 662 .

[0151] As shown in FIG. 15, the femoral probing system 710 also includes a femoral drill 800 that includes a plurality of cutting teeth 802 configured to remove portions of the patient's bone to prepare the bone for insertion of the femoral sleeve component 628. The cutting teeth 802 are formed in a stepped outer wall 804 having a configuration that matches the stepped outer wall 690 of the femoral sleeve component 628. The drill 800 has an opening 806 formed at its proximal end 808 and a threaded inner wall 810 shaped to accommodate the threaded distal end 756 of the shaft component 750. In an exemplary embodiment, drill 800 includes a distal hole sized to receive pins 730 of the femoral probe 20. Drill 800 also includes a thread (not shown) that is configured to engage the threaded end of a bolt 734 to attach drill 800 to the femur. trial component 20.

[0152] As shown in FIG. 16, the tibial prosthesis system 900 includes a tibial prosthesis component 18 configured to be connected to the surgically prepared proximal end of the patient's tibia. The tibial component 18 includes a tibial groove 902 configured to receive a polymeric liner or support component (not shown) for articulation with the condyles 604, 606 of the femoral prosthesis component 602. The trough 902 includes a platform 904 and a distal shaft pin 906 extending from the platform 904. A pair of keels 908 extend between the outer surface 910 of the distal shaft 906 and the platform 904. The platform 904 has a flat proximal surface 912 opposed to the distal shaft pin 906 and the keels 908 The tibial groove 902 also includes a posterior protrusion 914 that extends outward from a flat proximal surface 912. In an exemplary embodiment, the posterior protrusion 914 has a Y-shaped configuration. The tibial groove 902 also includes an anterior protrusion 916 that is spaced apart from a posterior protrusion 914 as shown in FIG. 16.

[0153] A shaft pin 906 extends to the distal end 918. An opening 920 is formed at the distal end 918 and a passage 922 extends inward from the opening 920. In an example embodiment, threads (not shown) cover the distal portion of the passage 922. The shaft pin 906 extends along the longitudinal axis 930. As shown in FIG. 16, the nail pin 906 is sized to fit into the patient's medullary canal, and the platform 904 is sized to fit over the canal opening and engage with the patient's proximal tibia. The platform 904 includes a curved outer wall 932 that includes a convex anterior section 934 and a concave posterior section 936 formed between the convex sections 938. The geometry of the curved outer wall 932 matches that of the surgically prepared proximal surface of the patient's tibia.

[0154] As shown in FIG. 16, the prosthesis system 900 also includes a stem component 940. The stem component 940 includes an elongate body 942 that extends from a proximal end 944 to a distal tip 946. At the proximal end 944, a plurality of threads 948 are formed that, in some configurations of the prosthesis assembly, may engage threads in the passage 922 of the tibial shaft 906. gutters 902.

[0155] The prosthesis system 900 also includes an offset adapter 960 that is configured to attach to the tibial component 18 and the stem component 940 to form an offset tibial prosthesis assembly 962. The offset adapter 960 includes a housing 964 that extends from a distal end 966 to a proximal end 968 offset from the distal end 966 as shown in FIG. 16. The body 964 includes a threaded shaft 970 that extends proximally from the proximal end 968 to the rim wall 972. The body 964 also includes a curved tapered surface 974 extending distally from the rim wall 972. The threaded shaft 970 is configured to engage threads in the passage 922 of the pin 906 for attaching the adapter 960 to the tibial component 18. The bias adapter 960 also includes a locking nut 976 threaded onto the shaft 970 that can be used to attach the bias adapter 960 to the tibial component 18, as described in more detail below.

[0156] The housing 964 also includes an opening 980 that is formed at the distal end 966. The opening 982 extends inwardly from the opening 980 and is sized to accommodate the threaded proximal end 944 of the shaft component 940. A plurality of threads extend into the hole 982 and are configured to engage with the threads 944 of the shaft component 940. As shown in FIG. 16, the bias adapter 960 defines a distal axis 986 that extends through the threaded hole 984 and along the longitudinal axis of the stem component 940. The offset adapter 960 also defines a proximal axis 988 that extends through the threaded shaft 970 and is aligned with the longitudinal axis 930 of the pin 906 of the tibial component 18. The axes 986, 988 are parallel but offset from each other. In an exemplary embodiment, body 964 is a one-piece monolithic component such that distal end 966 and proximal end 968 are secured to each other.

[0157] As shown in FIG. 17, the tibial probing system 1000 includes a tibial probing component 22 that is configured to be temporarily connected to the proximal end of a patient's tibia to assist in the surgical preparation of the patient's tibia for placement of the prosthesis tibial component 18. The tibial trial component 22 includes a base 1002 and a shank 1004 extending distally from the base 1002. The base 1002 is configured to receive a tibial trial insert (not shown) that pivots with the condyles 714, 716 of the femoral trial component 20. As shown in FIG. 17, the shaft pin 1004 is sized to fit into the patient's medullary canal, and the base 1002 is sized to fit over the canal opening and engage the proximal surface of the patient's tibia. The base 1002 includes a curved outer wall 1006 that includes a convex anterior section 1008 and a concave posterior section 1016 formed between the convex sections 1010. The geometric shape of the curved outer wall 1006 matches the outer wall 932 of the tibial duct 902 so that the surgeon can use a trial component 22 to make sure that the tibial groove is suitable for the patient. The tibial trial piece 22 includes a pair of placement tabs 1018 that extend from the base 1002.

[0158] In the exemplary embodiment, the tibial trial component 22 also includes a retaining bolt 1012 that is rotatably coupled to the base 1002. The bolt 1012 extends outward from the pin 1004 along the longitudinal axis 1014.

[0159] As shown in FIG. 17, trial system 1000 also includes a rod component 1020. The shaft component 1020 includes an elongated body 1022 that extends from the distal tip 1024 to the proximal end 1026. A plurality of threads 1028 are formed at the proximal end 1026.

[0160] The trial system 1000 also includes an offset adapter 1030 that is configured to attach to the tibial trial component 22 and the shaft component 1020 to form an offset tibial trial structure 1032. The offset adapter 1030 includes a two-piece housing 1034 that extends from the proximal end 1036 to a distal end 1038 offset from the proximal end 1036 as shown in FIG. 17. In an exemplary embodiment, the body 1034 includes a proximal sleeve 1040 that extends from the proximal end 1036 to the distal sleeve 1042. shaft component 1020 so as to find the optimal position on the patient's bone for the tibial offset prosthesis 962. The proximal sleeve 1040 includes a passageway 1044 that extends inwardly from the proximal end 1036 to a threaded hole (not shown) in the distal sleeve 1042. The size of the threaded hole provides placement of the threaded end of the bolt 1012 to secure the adapter 1030 to the tibial trial piece 22. As shown in FIG. 17, the distal sleeve 1042 also includes a curved tapered surface 1046 that connects the wider base of the distal sleeve 1042 to the narrower distal end 1038.

[0161] The body 1034 also includes an opening 1050 that is formed at the distal end 1038. The opening 1052 extends inwardly from the opening 1050. The opening 1052 is sized to accommodate the proximal end 1026 of the shaft component 1020. A plurality of threads (not shown) are formed in the hole 1052 and are sized to engage with the threads formed at the proximal end 1026 of the shaft component 1020.

[0162] As shown in FIG. 17, the bias adapter 1030 forms a distal axis 1060 that extends through the threaded hole 1052 and along the longitudinal axis of the shaft component 1020. The offset adapter 1030 also defines a proximal axis 1062 that is aligned with the longitudinal axis 1014 of the pin 1004 of the shaft of the trial component 22. The axes 1060, 1062 run parallel to, but are offset from each other by the same amount as the axes 986, 988 in the node 962 of the prosthesis .

[0163] As shown in FIG. 18-20, the system 10 also includes a sleeve impactor 1090 for use in attaching the femoral sleeve component 628 to the femoral component 16. The tool 1090 is a one-piece, monolithic component made of a metallic material such as, for example, stainless steel, which can be machined autoclaved and sterilized for reuse. The tool 1090 includes an elongated body 1092 that extends from the end 1094 of the femoral impactor to the end 1096 of the tibial impactor. In an exemplary embodiment, the end 1094 of the femoral impactor has an opening 1098 formed on the surface 1100 as shown in FIG. 18 and 20. Hole 1098 is sized to fit over the proximal end 694 of sleeve component 628. In an exemplary embodiment, opening 1098 is elongated and has an oval shape.

[0164] As shown in FIG. 19, the end 1096 of the tibial impactor has an opening 1102 formed on the surface 1104. The size of the opening 1102 allows it to be located over the distal end 1292 of the tibial sleeve component 1286 (see FIG. 46), as will be described in more detail below. In an exemplary embodiment, opening 1102 is circular in shape and provides clearance relative to the tibial base. Elongated body 1092 also has a pair of opposing flat surfaces 1106, 1108 to help stabilize tool 1090 at the end of each sleeve component and prevent tool rolling.

[0165] As described above, the orthopedic surgical instrument system 10 may be used during surgery to assemble the prosthesis components described above in FIG. 12-17. FIG. 21-47 show the various steps of the method for assembling a displaced femoral prosthesis assembly 662 (FIGS. 21-32 show a method for assembling a femoral sleeve assembly 704 (FIGS. 34-37), and FIGS. 38-43 show a method for assembling a displaced tibial assembly 962 prosthesis). It should be understood that the described methods and steps are given only as examples and do not exclude additional steps in accordance with the present description. In addition, all stages are shown for prostheses intended for use on only one patient's knee; it should be understood that similar steps may be carried out when assembling the prosthesis for the other knee.

[0166] During surgery, the surgeon may use a variety of cutting guide blocks, cutting tools, and other instruments to surgically prepare the patient's bones for placement to begin trial constructs 772, 1032. With the trial constructs mounted on the patient's bones, the surgeon may evaluate the fit trial designs 772, 1032 on the patient's bones. The surgeon may also perform a trial reduction to evaluate the range of motion with a trial insert placed between the constructs. Thus, the surgeon can determine the size of the tibial and femoral prosthesis for implantation into the patient's bone, as well as determine the desired orientation and position of the tibial and femoral components of the prosthesis relative to their respective shaft components.

[0167] During the trial portion of the surgery, the surgeon may rotate the femoral trial component 20 about the proximal axis 796 (and hence the stem component 750) of the offset adapter 770. To do this, the distal sleeve 780 of the offset adapter 770 is rotated relative to the proximal sleeve 782, which is secured to the nail component 750 in the medullary canal of the patient's femur. If the surgeon determines that the femoral probe 20 is properly seated on the patient's femur, the surgeon can use the bolt 734 to lock the distal sleeve 780 in position relative to the proximal sleeve 782, thereby locking the femoral probe 20 in the desired orientation and position relative to the component 750 rod.

[0168] Similarly, the surgeon may rotate the tibial trial component 22 about the distal axis 1060 (and hence the shaft component 1020) of the offset adapter 1030 to reposition the component 22 at the proximal end of the patient's tibia. To do this, the proximal sleeve 1040 of the offset adapter 1030 is rotated relative to the distal sleeve 1042, which is secured to the nail component 1020 in the medullary canal of the patient's tibia. If the tibial probe 22 is properly positioned on the patient's tibia, the surgeon can use the bolt 1012 to lock the proximal sleeve 1040 in position relative to the distal sleeve 1042, thereby locking the tibial probe 22 in the desired orientation and position relative to the shaft component 1020.

[0169] As shown in FIG. 21-32, the surgeon or other user may use the instrument system 10 to assemble the displaced femoral prosthesis assembly 662 based on the configuration of the femoral trial construct 772 constructed as described above. In other words, the surgeon may use the instrument system 10 to secure the femoral prosthesis component 16 to the shaft component 640 in a position and orientation that matches the desired orientation and position of the femoral trial component 20 as determined during surgery. Thus, the assembled displaced femoral prosthesis 662 follows and matches the configuration of the femoral trial construct 772.

[0170] To do this, the user may connect appropriate modular instruments 14 to the instrument base 12, including the support arm assembly 36 and the prosthesis femoral trial holder 30. As shown in FIG. 21, the user can align the support shaft 126 of the support bracket assembly 36 with the central passage 124 formed in the support pin 52 of the tool base 12. In addition, the mounting tab 130 of the support bracket assembly 36 is aligned with the upper end of the mounting slot 128. The user can then slide the mounting shaft 126 into the center passage 124 and the mounting tab 130 into the mounting slot 128. handle 258 pivots about support pin 52. When properly mounted on support pin 52, elongate handle 258 aligns with vertically extending orientation plane 270 as shown in FIG. 21.

[0171] To connect the prosthesis femoral trial holder 30 to the instrument base 12, the user may align the orienting holes 320, 322 with the cylindrical pin 104 and polyhedral pin 106, respectively, on the base platform 42. The user can then slide the holder 30 over the studs 104, 106 to position the support block 330 of the holder 30 on the platform 42. If the locking mechanism 56 is in the unlocked position, the user can rotate the platform 42 (and hence the femoral prosthesis trial holder 30) around axis 38 to install the prosthesis femoral trial holder 30 as shown in FIG. 22.

[0172] As shown in FIG. 22-23, the user may place the femoral trial assembly 772 on the femoral trial holder 30 of the prosthesis. To do this, the user may place the femoral trial structure 772 over the mounting pin 352 and the shaft 332 of the femoral trial holder 30 of the prosthesis. As shown in FIG. 23, the user aligns the distal opening 1200 of the hole 732 formed in the femoral trial component 20 with the placement pin 352. The user can push the femoral trial assembly 772 down so that the pin 352 and the top end of the pin 332 are seated in the hole 732. The pin 352 enters the recess (not shown) of the bolt 734 of structure 772 and the wall 364 is located in the intercondylar slot 718 of the femoral trial component 20. As shown in FIG. 22, the surgical instrument system 10 also includes a support pad 1202 that is located on the wall 364 and is sized to fit into the intercondylar slit 718 to hold the femoral probe 20 on the holder 30.

[0173] In FIG. 6, gasket 1202 is shown in more detail. Gasket 1202 includes a housing 1204 that extends from end surface 1206 to opposite end surface 1208 along longitudinal axis 1210. Housing 1204 includes a bottom opening 1212 that extends from surface 1206 to surface 1208 along axis 1210. Gasket 1202 includes a pair of inner side walls 1214, 1216 that extend upward from opening 1212 to curved base wall 1218. Walls 1214, 1216, 1218 define a channel 1220 in gasket 1202, sized to accommodate walls 362, 364 of holder 30. In an exemplary embodiment, gasket 1202 also includes a groove 1222 formed in sidewall 1214. Groove 1222 is sized to accommodate ribs 370 of the holder 30 so that the gasket 1202 can be installed on each of the walls 362, 364 in only one orientation.

[0174] In an exemplary embodiment, gasket 1202 is formed from a material such as a polymer. It has a width or thickness of 1230 defined by the distance between a pair of flat side surfaces 1232. As also shown in FIG. 23, the thickness 1230 of the pad 1202 is approximately equal to the width 1234 of the intercondylar slit 718. The width 1234 is determined by the distance between the side walls 720 of the femoral trial component 20. It should be understood that the system 10 includes a plurality of pads of various thicknesses corresponding to different sizes of the femoral trial components 20 and the femoral components 16 of the prosthesis.

[0175] As shown in FIG. 24, the femoral trial assembly 772 rests on the holder 30 and spacer 1202. In this position, the axis 740 of the femoral trial component 20 and the axes 796, 798 formed by the offset adapter 770 run parallel to the axis 38 of the instrument base 12. As shown in FIG. 26 which is a cross-sectional view taken along line 26-26 in FIG. 24, pin 332 and dowel pin 352 also run parallel to the indicated axes. In an exemplary embodiment, the non-orthogonal angle 1236 formed between the wall 364 and the support block 330 of the holder 30 is equal to the non-orthogonal angle 1238 formed between the flat surface 742 and the axis 740 of the femoral trial component 20 such that the axes 740, 796, 798 are parallel to the axis 38 grounds 12.

[0176] Once the femoral trial construct 772 is installed on the femoral trial prosthesis holder 30, the assembly can be rotated in any direction shown by arrow 1240 in FIG. 24 to orient the femoral trial structure 772 relative to the support arm assembly 36. In an exemplary embodiment, the femoral trial structure 772 rotates to accommodate the axles 740, 796, 798 in a vertically extending alignment plane 270 that is formed by the axle 38 and the axle 260 of the support arm assembly 36. In addition, the axle 798 is positioned between the axle 796 and the support bracket assembly 36 in the alignment plane 270 such that the proximal sleeve 782 is closer to the bracket assembly 36 than the distal sleeve 780 of the offset adapter 770. When properly installed, the user can extend the tip 264 of the support arm assembly 36 along the axis 260 towards the femoral trial structure 772 as shown by arrow 1242 in FIG. 24.

[0177] As shown in FIG. 25, the shafts 278, 280 extend over the femoral trial structure 772 to position the bias adapter 770 at the proximal end 288 of the channel 282 of the support arm 36. The user can verify that the femoral trial structure 772 is properly oriented by checking that the tapering surface 786 of the adapter The offset 770 faces away from the bracket 36 and is aligned with the rounded end walls 284 of the shafts 278, 280. In some embodiments, as shown in FIG. 26, the user can verify that the femoral trial construct 772 is properly oriented by verifying that visual indicators, such as line 1244 on bias adapter 770, for example, are facing toward bracket 36 and aligned with channel 282.

[0178] As also shown in FIG. 25, the user may actuate the tension mechanism 300 to secure the femoral trial construct 772 to the support bracket 36. To do this, the user may rotate the handle 302 about its axis to screw the elongated shaft 304 into the threaded hole 308 to bring the shafts 278, 280 closer together. to friend. As the shafts 278, 280 approach, the channel 282 becomes narrower and the shafts 278, 280 engage with the offset adapter 770.

[0179] The user can actuate the locking mechanism 56 to lock the platform 42 in a certain position relative to the bracket 36 and the body 40 of the base 12. To do this, the user can hold the grip 146 of the handle 140 and rotate the handle 140 in the direction indicated by arrow 224 in FIG. 25. As the handle 140 is rotated, the cam 170 of the locking mechanism 56 rotates to bring the teeth 202 into engagement with the teeth 102 of the platform 42, thereby locking the platform 42 in position relative to the body 40. The base 12 of the instrument can now reproduce the position and orientation of the femoral trial design. 772 and ready to begin assembly of the 600 Offset Hip Prosthesis.

[0180] The user can actuate the tightening mechanism 300 to release the barrels 278, 280 and the bias adapter 770. The support arm 36 can be retracted from the femoral trial structure 772 so that the femoral trial structure 772 can be detached from the holder 30. The user also detaches the holder 30 from the instrument base 12. During all these operations, the handle 140 (and hence the locking mechanism 56) remains in the locked position to prevent the platform 42 from rotating relative to the body 40.

[0181] As shown in FIG. 28, the user may place the prosthesis femoral holder 32 on the platform 42 by placing holes 320, 322 over the respective studs 44 of the platform 42 in a similar manner to the prosthesis femoral trial holder 30 described above. The user can install the same support pad 1202 on the wall 464 of the holder 32, as shown in FIG. 28. The femoral component 16 of the prosthesis corresponding to the femoral trial component 20 can align with the pin 432 of the holder 32 and move over the pin 432 to set the component 16 in a certain position, as shown in FIG. 29-30.

[0182] As shown in FIG. 31 which is a cross-sectional view along line 31-31 in FIG. 29, a pin 432 is received at the proximal exit of the opening 622 of the femoral component 16. In an exemplary embodiment, the non-orthogonal angle 1246 formed between the wall 464 and the support block 430 of the holder 32, which is equal to the non-orthogonal angle 1248 formed between the flat surface 632 and the axis 630 of the femoral component 16 , defines the position of the axis 630 parallel to the axis 38 of the base 12 and in the orientation plane 270. As described above, the holder 32 includes a section 476 that reduces the thickness of the block 430 on one side. As shown in FIG. 31, this reduced thickness maintains a gap 1252 between the block 430 and the condyle 606 of the femoral component 16.

[0183] As shown in FIG. 29, the user can connect the offset adapter 660 to the femoral component 16. To do this, the user can align the threaded shaft 670 with the pin 616 of the femoral component 16 and insert the threaded shaft 670 into the hole 622. The shaft 670 rotates about its axis 686 to extend the lock nut 676 ( which is pressed against the wall 672 of the rim of the adapter 660) in contact with the pin 616. After locking the lock nut 676 on the pin 616, the user can rotate the proximal end 668 of the adapter 660 about the axis 686 to move the curved tapered surface 674 away from the support bracket assembly 36, as shown in FIG. 30. In this position, the axles 630, 686, 688 are located in a vertically extending alignment plane 270. In addition, the axle 686 is located between the axle 688 and the support bracket assembly 36 in the alignment plane 270 so that the proximal end 668 of the offset adapter 660 is located closer to the assembly 36 bracket than the distal end of 666.

[0184] The user can position the offset adapter 660 in the channel 282 of the support bracket 36 by extending the bracket tip 264 in the direction of the offset adapter 660. When the adapter 660 is positioned in the channel 282, the user may actuate the tension mechanism 300 to secure the bias adapter 660 to the support bracket 36. To do this, the user may rotate the handle 302 about its axis to screw the elongated shaft 304 into the threaded hole 308 to bring the shafts together. 278, 280 are closer to each other. As the stems 278, 280 approach each other, the channel 282 becomes narrower and the stems 278, 280 engage with the bias adapter 660 as shown in FIG. thirty.

[0185] Once the bias adapter 660 is engaged in the support bracket assembly 36, the user may use a torque wrench (not shown) to tighten the lock nut 676 on the pin 616 to increase the preload of the components 16, 660. In the exemplary embodiment, the preload provides stretching between the threaded section 624 of the pin 616 and the threaded shaft 670, thereby fixing the component 16 on the offset adapter 660.

[0186] As shown in FIG. 32, a user may select a shaft component 640 for the prosthesis 662 based on the configuration (eg, length) of the shaft component 750. The user can then connect the rod component 640 to the proximal end 668 of the offset adapter 660 by screwing the distal end 644 of the rod component 640 into the threaded hole 684 of the proximal end 668. The user can use a torque wrench (not shown) to tighten the rod component 640 onto the adapter 660 offset to add preload to the components 640, 660 and form the offset prosthesis 662. Thus, the orientation and placement of the offset trial structure 772 is reproduced in the offset prosthesis 662. The user can then detach the support bracket assembly 36 from the prosthesis 662 and remove the prosthesis 662 from the holder 32 for implantation in the patient's femur.

[0187] As shown in FIG. 33, tool base 12, holder 32, and other tools of system 10 can be used to assemble the straight shaft femoral prosthesis 1250. In an exemplary embodiment, a straight shaft femoral prosthesis 1250 includes a femoral component 16 and a nail component 640 that attaches to a shaft 616 of the femoral component 16. As shown in FIG. 33, the femoral component 16 is positioned on the base 12 in a manner similar to that described above. It should be understood that the support bracket 36 extends over the shaft component 640 and is actuated to limit movement of the shaft component 640 during the tightening process described above.

[0188] As shown in FIG. 34-37, sleeve holder 32 and sleeve impactor 1090 may be used to assemble a femoral prosthesis sleeve assembly 704. To do this, the femoral component 16 is mounted on the holder 32 and the spacer 1202, as shown in FIG. 34 in the same manner as described above. The sleeve component 628 can then be extended over the pin 616 of the femoral component 16. As shown in FIG. 35, a pin 616 is received in a hole formed at the distal end 692. As described above, the distal hole is formed by a tapered inner surface that matches the tapered outer surface 626 of the pin 616 such that the sleeve component 628 can be attached to the pin 616 by means of a cone lock.

[0189] To form a conical lock, the user may use the sleeve impactor 1090 to engage the proximal end 694 of the sleeve component 628. As shown in FIG. 36, the proximal end 694 of the sleeve component 628 is located in the opening 1098 formed at the end 1094 of the femoral impactor. The user may use a hammer or other tool to strike the end 1096 of the tibial impactor to advance the sleeve component 628 along the pin 616 and form a cone lock.

[0190] As described above, the sleeve component 628 is configured to attach to the shaft component 640. To do this, the threaded distal end 646 of the shaft component 640 engages in a threaded connection with a threaded hole 650 formed at the proximal end 694 of the sleeve component 628. The user may use a torque wrench (not shown) to tighten the stem component 640 on the sleeve component 628 to preload the components 628, 640 and form the prosthesis sleeve assembly 704.

[0191] To hold the sleeve component 628 in position while applying torque to the stem component 640, the user may use a wrench 1260 shown in FIG. 37. The wrench 1260 includes an elongated handle 1262 and a head 1264 attached to the handle 1262. The head 1264 includes a pair of arms 1266, 1268 that form a mouth 1270 sized to accommodate the proximal end 694 of the sleeve component 628. Each arm 1266, 1268 includes a plurality of surfaces 1274 that form a throat 1270 and a plurality of protrusions 1272 that extend from the surfaces 1274 into the throat 1270. Each protrusion 1272 is rounded and configured to mount on flat surfaces (as opposed to edges) of the proximal end 694 sleeve 628.

[0192] As described above, during surgery, surgeons may place the tibial trial construct 1032 on the patient's tibia and rotate the tibial trial component 22 about the distal axis 1060 (and hence the shaft component 1020) of the offset adapter 1030 to change the position of the trial component 22 at the proximal end of the patient's tibia. If the tibial probe 22 is properly positioned on the patient's tibia, the surgeon can use the bolt 1012 to lock the proximal sleeve 1040 of the offset adapter 1030 in position relative to the distal sleeve 1042, thereby locking the tibial probe 22 in the desired orientation and position relative to the shaft component 1020 .

[0193] As also shown in FIG. 38-43, the tool system 10 can be used to assemble a displaced tibial prosthesis assembly 962 based on the configuration of a tibial trial construct 1032 constructed as described above. In other words, the surgeon may use the instrument system 10 to attach the tibial prosthesis component 18 to the shaft component 940 in a position and orientation that matches the desired orientation and position of the tibial trial component 22 as determined during surgery. Thus, the assembled offset tibial prosthesis 962 follows and matches the configuration of the tibial trial construct 1032.

[0194] To do this, the user may connect the respective modular instruments 14 to the instrument base 12, including the support arm assembly 36 and the tibial component holder 34. To connect the tibial component holder 34 to the instrument base 12, the user may align the orienting holes 320, 322 with the cylindrical pin 104 and polyhedral pin 106, respectively, on the base platform 42, as shown in FIG. 38. The user can then slide the holder 34 over the studs 104, 106 to install the support block 500 of the holder 34 on the platform 42. If the locking mechanism 56 is in the unlocked position, the user can rotate the platform 42 (and hence the holder 34) around the axis 38 to install the holder 34 as shown in FIG. 39.

[0195] The user may mount the tibial trial design 1032 on the holder 34 as shown in FIG. 39. In the exemplary embodiment, bar component 1020 of structure 1032 has been detached for clarity. It should be understood that the rod component 1020 can be attached at any of the steps described below. To connect the structure 1032 to the holder 34, the user aligns the tabs 1018 of the trial piece 22 with the Y-channel 560 formed in the clamp bar 504. The user can then move the base 1002 of the trial piece 22 into contact with the tabs 556, 558 of the clamp bar 504. As shown in FIG. 39, the inner wall 566 of the jaw 562 is located between the back sections 1010 and in the concave back section 1016. The front wall section 1008 faces the jaw 542 of the holder 34. The user can then use the handle 580 to push the jaws 542, 562 towards each other and lock between them base 1002.

[0196] As shown in FIG. 39, the tibial trial construct 1032 is positioned on the holder 34. In this position, the axes 1014, 1060, 1062 run parallel to the axis 38 of the instrument base 12. Once the tibial trial structure 1032 is in place on the holder 34, the assembly can be rotated in any direction shown by arrow 1240 to orient the tibial trial construction 1032 relative to the support bracket assembly 36. In an exemplary embodiment, the tibial trial structure 1032 is rotated to position the axles 1014, 1060, 1062 in the vertically extending alignment plane 270. In addition, the axle 1062 is positioned between the axle 1060 and the support arm assembly 36 in the alignment plane 270 such that the distal sleeve 1042 is closer to the bracket assembly 36 than the proximal sleeve 1040 of the offset adapter 1030. When properly installed, the user can extend the tip 264 along the axis 260 in the direction of the tibial trial design 1032, as indicated by arrow 1242.

[0197] As shown in FIG. 40, the shafts 278, 280 are extended over the tibial trial structure 1032 to position the offset adapter 1030 at the proximal end 288 of the channel 282 of the support bracket 36. The user can verify that the tibial trial structure 1032 is properly oriented by checking that the tapering surface 1046 of the adapter The offset 1030 faces away from the bracket 36 and is aligned with the rounded end walls 284 of the shafts 278, 280. In some embodiments, the user can verify that the tibial trial design 1032 is properly oriented by checking that the visual indicators printed on the offset adapter 1030 are facing in the direction of bracket 36 and aligned with channel 282.

[0198] The user may actuate the tension mechanism 300 to secure the tibial trial construct 1032 to the support bracket 36. To do this, the user may rotate the handle 302 around its axis to screw the elongate shaft 304 into the threaded hole 308 to bring the shafts 278, 280 closer together. to each other. As the shafts 278, 280 approach each other, the channel 282 narrows and the shafts 278, 280 engage the bias adapter 1030. The user may also actuate the locking mechanism 56 to lock the platform 42 in position relative to the bracket 36 and body 40 of the base 12. To do this, the user may hold the grip 146 of the handle 140 and rotate the handle 140 in the direction indicated by arrow 224 in FIG. 40.

[0199] After the platform 42 is locked to rotate, the user can actuate the tension mechanism 300 to release the shafts 278, 280 and the bias adapter 1030. The support bracket 36 can be moved away from the tibial trial structure 1032 so that the tibial trial structure 1032 can be detached from the holder 34.

[0200] A tibial prosthesis component 18, such as a trough 902 corresponding to the tibial trial component 22, may be attached to a holder 34 instead of the tibial trial construct 1032 as shown in FIG. 41. To do this, the user aligns the Y-shaped protrusion 914 of the trough 902 with the Y-shaped channel 560 formed in the clamp bar 504. The user can then move the platform 904 of the tibial groove 902 into contact with the pads 556, 558 of the clamp bar 504. As shown in FIG. . 39, the inner wall 566 of the jaw 562 is located between the back sections 938 and in the concave back section 936. The front wall section 934 faces the jaw 542 of the holder 34. The user can then use the handle 580 to push the jaws 542, 562 towards each other and fix the tibial groove 902 between them.

[0201] As shown in FIG. 42, the user may connect the offset adapter 960 to the tibial groove 902. To do this, the user may align the threaded shaft 970 with the pin 906 of the tibial groove 902 and extend the threaded shaft 970 into the hole 922. The shaft 970 rotates about its axis 988 to extend the lock nut 976 ( which is pressed against the wall 972 of the rim of the adapter 960) into contact with the pin 906. After installing the lock nut 976 on the pin 906, the user can rotate the distal end 966 of the adapter 960 about the axis 988 to move the curved tapered surface 974 away from the support bracket assembly 36, as shown in FIG. 42. In this position, the axles 930, 986, 988 are located in a vertically extending alignment plane 270. In addition, the axle 988 is located between the axle 986 and the support bracket assembly 36 in the alignment plane 270 such that the distal end 966 of the offset adapter 960 is closer to the assembly 36 bracket than the distal end of 666.

[0202] The user can position the offset adapter 960 in the channel 282 of the support bracket 36 by extending the tip 264 of the bracket in the direction of the offset adapter 960. When the adapter 960 is positioned in the bore 282, the user may actuate the tension mechanism 300 to secure the offset adapter 960 to the support bracket 36. To do this, the user may rotate the handle 302 about its axis to screw the elongated stem 304 into the threaded hole 308 to bring the stems together. 278, 280 are closer to each other. As the stems 278, 280 approach each other, the channel 282 becomes narrower and the stems 278, 280 engage with the bias adapter 960 as shown in FIG. 43.

[0203] Once the bias adapter 960 is engaged in the support bracket assembly 36, the user may use a torque wrench (not shown) to tighten the lock nut 976 on the pin 906 to increase the preload of the components 18, 960. In the exemplary embodiment, the preload provides stretching between the threads in the hole 922 of the pin 616 and the threaded shaft 970, thereby fixing the component 18 on the offset adapter 960.

[0204] The user may select a shaft component 940 for the prosthesis 962 based on the configuration (eg, length) of the shaft component 1020. The user can then connect the rod component 940 to the distal end 966 of the bias adapter 960 by screwing the proximal end 944 of the rod component 940 into the threaded hole 982 of the adapter 960. The user can use a torque wrench (not shown) to tighten the rod component 940 onto the bias adapter 960 to preload the components 940, 960 and form the offset prosthesis 962. Thus, the orientation and placement of the offset trial structure 1032 is reproduced in the offset prosthesis 962. The user can then detach the support bracket assembly 36 from the prosthesis 962 and remove the prosthesis 962 from the holder 34 for implantation in the patient's tibia.

[0205] As shown in FIG. 44-47, the tool base 12, holder 34, and other tools of the system 10 can be used to assemble the sleeve of the tibial prosthesis 1280. In an exemplary embodiment, the prosthesis 1280 includes a tibial groove 1282 similar to the tibial groove 902, except for a longer and tapered pin 1284 rod as shown in FIG. 44. The prosthesis 1280 also includes a sleeve component 1286 configured to be placed on a tapered shaft pin 1284 as shown in FIG. 45. The sleeve component 1286 includes a stepped outer wall 1290 and a tapered inner wall (not shown) configured to lock the sleeve component 1286 and the tibial groove 1282 with a cone lock.

[0206] As shown in FIG. 44, the tibial groove 1282 is mounted on the base 12 using the holder 34 in a similar manner as described above. It will be appreciated that support bracket 36 is not required to assemble the sleeve of the tibial prosthesis 1280. Once the tibial trough 1282 is in place on the holder 34, the sleeve component 1286 extends over the pin 1284 as shown in FIG. 45.

[0207] To form a conical lock, the user may use the sleeve impactor 1090 to engage the distal end 1292 of the sleeve component 1286. As shown in FIG. 46, the distal end 1292 of the sleeve component 1286 is located in the opening 1102 formed at the end 1096 of the tibial impactor. The user may use a hammer or other tool to strike the end 1094 of the femoral impactor to advance the sleeve component 1286 along the pin 1284 and form a cone lock.

[0208] The pin 1284 of the tibial groove 1282 is configured to attach to the component 940 of the rod. To do this, the threaded proximal end 944 of the shaft component 940 engages in a threaded connection with a threaded hole 1294 formed at the distal end 1296 of the pin 1284, as shown in FIG. 47. The user may use a torque wrench (not shown) to tighten the shaft component 940 on the tibial groove 1282 to add preload to the components 940, 1282 and form the prosthesis sleeve assembly 1280.

[0209] Although the description is detailed in the figures and in the text above, such presentation and description should be considered illustrative and not restrictive, it being understood that only illustrative embodiments are presented and described herein and that the scope of protection extends to all changes and modifications within the scope of the invention intended to protect the essence of the invention.

[0210] The present description has many advantages due to various elements of the method, device and system described in this document. It should be noted that alternative embodiments of the method, apparatus, and systems of the present disclosure may not include all of the elements described, but may still have at least some of the benefits associated with such elements. Those skilled in the art are readily able to develop their own implementations of the method, apparatus, and system incorporating one or more of the elements of the present invention and consistent with the spirit and scope of the present disclosure, as defined by the appended claims.

Claims (57)

1. A method for assembling a tibial component of a knee joint prosthesis, including: combining the tibial trial structure with a surgical instrument, which includes a support platform and a stabilizing bracket, while the tibial trial structure contains a trial base, which forms the first axis, and a trial offset adapter, which forms the second axis, displaced relative to the first axis, location of the tibial trial structure on the supporting platform, pivoting the support platform to accommodate the first axle and the second axle in a plane passing vertically through the stabilizing bracket, extension of the stabilizing arm along a vertically passing plane to engage the stabilizing arm with the tibial trial structure, blocking the support platform to prevent rotation relative to the stabilizing bracket, placing the tibial prosthesis component on the support platform after removing the tibial trial structure so that the third axis formed by the distal pin of the tibial prosthesis component is in the plane, placement of the tibial displacement adapter on the distal pin, wherein the tibial displacement adapter includes a distal end that forms a fourth axis offset from the third axis, pivoting the distal end of the tibial offset adapter to accommodate the fourth axis in a vertical plane, and attaching the tibial offset adapter to the tibial prosthesis component with the third axis and fourth axis in plane. 2. The method of claim. 1, further comprising fastening the holder to the support platform, wherein installation of the tibial trial structure on the support platform includes placing the tibial trial structure on the holder and extending the first clamping bar of the holder into engagement with the trial base of the tibial trial structure for attaching the trial base between the first clamping bar and the second clamping bar of the holder. 3. The method of claim 2, wherein placing the tibial prosthesis component on the support platform after removal of the tibial trial construct includes: the location of the tibial trial component on the holder and extending the first clamp bar into engagement with the tibial trial piece to secure the tibial prosthesis component between the first clamp bar and the second clamp bar. 4. The method of claim 1, further comprising attaching the shaft component to the distal end of the tibial bias adapter. 5. The method of claim 1, further comprising extending the stabilizing arm along the vertically extending plane to engage the stabilizing arm with the distal end of the tibial offset adapter after rotating the distal end of the tibial offset adapter to position the third axis in the vertically extending plane. 6. The method of claim 5, wherein extending the stabilizing arm along a vertically extending plane to engage the stabilizing arm with the distal end of the tibial bias adapter comprises positioning the distal end of the tibial bias adapter in a channel formed in the stabilizing arm. 7. The method of claim 6 wherein extending the stabilizing arm along a vertically extending plane to engage the stabilizing arm with the trial bias adapter comprises placing the trial bias adapter in a channel formed in the stabilizing arm. 8. The method of claim 7, further comprising attaching a trial bias adapter to the proximal tip of the stabilizing arm prior to locking the support platform to prevent rotation relative to the stabilizing arm. 9. The method of claim 7, further comprising aligning the visual indicators on the trial bias adapter with an alignment window formed in the stabilizing bracket. 10. The method of claim 7, wherein extending the stabilizing arm along a vertically extending plane to engage the stabilizing arm with the bias trial adapter further comprises aligning the beveled end surface of the proximal tip with the tapered surface of the bias trial component. 11. A method for assembling a tibial component of a knee joint prosthesis, including: rotation of the support platform of the surgical instrument around a vertical axis, fastening the holder to the support platform, placing the first tibial component of the prosthesis on the holder, wherein the first tibial component includes a tibial groove and a pin extending from the tibial groove, extending the first clamp bar of the holder into engagement with the tibial groove to secure the tibial groove between the first clamp bar and the second clamp bar of the holder, and attaching the second tibial prosthesis component to the pin of the first tibial prosthesis component, wherein attaching the second tibial prosthesis component to the pin of the first tibial prosthesis component includes shifting the second tibial prosthesis component along the tapering outer surface of the pin to attach the second tibial prosthesis component to the pin, wherein the second tibial prosthesis component includes a stepped outer surface, wherein attaching the second tibial prosthesis component to the pin of the first tibial prosthesis component further comprises connecting the first end of the impactor to the distal end of the second tibial prosthesis component and applying force to the second end of the impactor. 12. The method according to claim 11, in which the pin of the first tibial component of the prosthesis forms the first axis and attaching the second tibial prosthesis component to the pin of the first tibial prosthesis component includes: rotating the distal end of the second tibial prosthesis component to accommodate the second axis formed by the distal end in a vertically extending plane, and fastening the second tibial prosthesis component to the pin of the first tibial prosthesis component, wherein the first axis and the second axis are in a vertically passing plane. 13. The method of claim 12, further comprising extending the surgical instrument stabilizing arm along a vertical plane to position the stabilizing arm over the distal end of the second tibial prosthesis component, and attaching the second tibial prosthesis component to the stabilizing arm. 14. The method of claim 13, wherein the stabilizing arm has an elongated body that extends along a vertically extending plane. 15. The method of claim 13 wherein extending the stabilizing arm along a vertically extending plane to position the stabilizing arm over the distal end of the second tibial prosthesis component includes positioning the distal end of the second tibial prosthesis component in a channel formed between the proximal tip of the stabilizing arm. 16. The method of claim 11, further comprising: location of the tibial trial structure on the holder, while the tibial trial structure contains a trial base, which forms the axis of the base, and a displacement trial component, which forms the axis of the rod, displaced relative to the axis of the base, extending the stabilizing arm of the surgical instrument along a vertically passing plane to engage the stabilizing arm with the tibial trial construct, locking the support platform to prevent rotation relative to the stabilizing arm, and separating the tibial trial construction from the holder before installing the first tibial component of the prosthesis on the holder, wherein the rotation of the support platform of the surgical instrument includes the rotation of the holder and the tibial trial structure to transfer the axis of the base and the axis of the rod into a vertically passing plane. 17. A method for assembling a tibial component of a knee joint prosthesis, including: combining a trial prosthesis assembly with a surgical instrument that includes a support platform and a stabilizing bracket, while the trial prosthesis assembly contains a trial prosthesis component that forms the first axis, and a trial offset adapter that forms a second axis offset relative to the first axis, the location of the trial unit of the prosthesis on the supporting platform, pivoting the support platform to accommodate the first axle and the second axle in a plane passing vertically through the stabilizing bracket, extending the stabilizing arm along a vertically passing plane to engage the stabilizing arm with the prosthesis test assembly, blocking the support platform to prevent rotation relative to the stabilizing bracket, location of the prosthesis component on the support platform after removal of the trial prosthesis assembly so that the third axis formed by the pin of the prosthesis component is in a plane, while the dimensions and shape of the prosthesis component correspond to the dimensions and shape of the trial prosthesis assembly, placement of the offset adapter on the pin, wherein the offset adapter includes an end that forms a fourth axis offset relative to the third axis by an amount equal to the offset of the first axis and the second axis, turning the end of the offset adapter to accommodate the fourth axis in the vertical plane, and attaching the offset adapter to the prosthesis component with the third axis and fourth axis in a plane. 18. The method of claim 17 wherein the prosthesis component is a tibial prosthesis component and the prosthesis trial component is a tibial trial component. 19. The method of claim 17 wherein the prosthesis component is a femoral prosthesis component and the prosthesis trial component is a femoral trial component.

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