Knee prosthesis implant system and method involving associated tibial rotation

Abstract

A tibial spacer (10) includes a spacer block (16) including opposing bearing surfaces (18A, 18B), an alignment slot (14) extending into the spacer block, and a handle extending from the spacer block. The spacer block can include feet (12A, 12B) for passively engaging the femur or pegs (112A, 112B) for actively engaging the femoral component such that the spacer block is connected to the femur as the tibia rotates. A tibial spacer system includes a temporary component having an alignment tab (222) extending from a body and an alignment indicator on the body, a femoral component (240) and a pin (264) extending from the femoral component. The pin can engage the alignment tab such that the temporary component is connected to the femur as the tibia rotates. In addition to or as an alternative to the alignment tab and pin, the temporary component can include a tibial plate (30) that is rotatably connected to the temporary component.

Description

[0001] This application is a divisional application of the invention patent application filed on February 23, 2018, with application number 201880014269.1 and entitled "Knee Prosthesis Implantation System and Method Involving Related Tibial Rotation".

[0002] Priority Statement

[0003] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 464076, filed February 27, 2017, the entire contents of which are incorporated herein by reference. Technical Field

[0004] This document relates generally to, but is not limited to, orthopedic implant systems and methods for knee arthroplasty. More specifically, this disclosure relates to, but is not limited to, orthopedic devices and methods for matching the internal / external rotation of the tibial component with the internal / external rotation of the femoral component. Background Technology

[0005] A natural knee joint typically undergoes a degree of rotation between the tibia and femur during flexion. Specifically, the femur can rotate relative to the tibia in the transverse plane. Therefore, when implanting one or more orthopedic femoral and tibial components, it may be desirable to replicate the natural rotational alignment of the tibia and femur.

[0006] Typically, the rotation of the tibial component is independent of the femoral component setting and depends solely on the tibial bone landmarks. In some cases, this can lead to undesirable rotation of the tibial component relative to the femoral component. In these cases, if a highly fitted articulation design is used between the femur and tibia, the matching tibial-femoral articulation surfaces will drive the tibial component to rotate and align with the femoral component when the prosthesis is loaded. This movement of the tibial component will cause the entire tibia to rotate relative to the femur into a non-physiological orientation. This can lead to pain, stiffness, and abnormal knee sensation.

[0007] Some surgeons attempt to match the natural rotation of the tibia using a technique called “tibial floating.” In this method, a femoral trial is placed, and trial reduction is performed by placing a tibial support within a tibial size adjustment tray that can rotate and translate freely on a surface near the tibial resection site. Thus, the tibial size adjustment tray “floats” freely between the resected tibia and the femoral trial. The knee joint undergoes a series of movements and then extends to full extension. The surgeon then uses a pen or electrocautery (Bovie) to mark points on the tibia corresponding to the anterior portion of the tibial size adjustment plate. The inherent assumption of this method is that the fit between the support and the femoral component will force the support (and therefore the tibial size adjustment plate) to move and align with the rotation of the femoral component.

[0008] Examples of prosthetic knee implants are described in U.S. Patent No. 5,782,925 to Collazo et al. and U.S. Patent No. 9,211,189 to Earl et al. Summary of the Invention

[0009] The inventors have recognized potential problems when attempting to use the "floating tibia" technique to match the natural rotation of the tibia and femur. First, when the knee is fully extended, the tibial component may be under compressive load from the femur, which can inhibit relative movement of the tibial component on the tibia. Second, current total knee arthroplasty (TKA) joint connections can be designed with a degree of rotational laxity. The fit of the femoral component may be insufficient to drive movement of the tibial component, especially when the tibial component is under compressive load. Third, when surgeons mark points on the anterior bone to indicate the anterior portion of the tibial specimen, there are typically no corresponding marks on the posterior tibia to define the axis of rotation. Surgeons can align with the anterior marks but need to estimate the orientation of the posterior portion of the tibial specimen.

[0010] This topic can help provide solutions to various problems related to matching the natural rotation of the tibia with the femur when implanting prosthetic knee components.

[0011] In one example, this topic can help provide solutions to these problems, for instance, by providing a tibial spacer that may include a spacer block, first and second legs, first and second alignment chamfers, alignment grooves, and a handle. The spacer block may include a first support surface, a second support surface disposed opposite to the first support surface, and an edge peripheral region connecting the first and second support surfaces. The first leg may extend from the first support surface at the edge peripheral region. The second leg may extend from the first support surface at the edge peripheral region, spaced apart from the first leg. The first alignment chamfer may extend into the edge peripheral region and the second support surface, opposite to the first leg. The second alignment chamfer may extend into the edge peripheral region and the second support surface, opposite to the second leg. The alignment groove may extend into the edge peripheral region, opposite to the first and second legs. A handle may extend from the spacer block.

[0012] In another example, the tibial spacer system may include a spacer block, a first stud, a second stud, an alignment groove, and a handle. The spacer block may include a first support surface, a second support surface disposed opposite to the first support surface, and an edge peripheral region connecting the first and second support surfaces. The first stud may extend from the first support surface. The second stud may extend from the first support surface, spaced apart from the first stud. The alignment groove may extend into the edge peripheral region. The handle may extend from the spacer block.

[0013] In yet another example, the tibial spacer system may include a temporary component and a sizing extension. The temporary component may include a body, an articular engagement surface positioned on the body and configured to engage the condylar surface of the femoral component, and an alignment tab extending from the body. The sizing extension may extend from the body from the opposite side of the articular engagement surface. The sizing extension may include a bone engagement surface, a peripheral region extending from the bone engagement surface, and a first alignment indicator located on the peripheral region of the sizing extension.

[0014] In yet another example, the tibial spacer system may include a temporary component, a specimen support, and a pivot connection. The temporary component may include an articular engagement surface configured to engage the condylar surface of the femoral component, a first support surface disposed opposite to the articular engagement surface, and a first peripheral region connecting the articular engagement surface and the first support surface. The specimen support may include a bone engagement surface, a second support surface disposed opposite to the bone engagement surface, and a second peripheral region connecting the bone engagement surface and the second support surface. The pivot connection may connect the first support surface and the second support surface. The pivot connection may be configured to allow rotation of the specimen support relative to the temporary component.

[0015] The content of this invention is intended to provide an overview of the subject matter of this patent application. It is not intended to provide an exclusive or exhaustive explanation of the invention. Detailed descriptions are included to provide further information regarding this patent application. Attached Figure Description

[0016] Figure 1 It is a perspective view of the tibial septum with alignment feet and alignment grooves.

[0017] Figure 2 yes Figure 1 A side view of the tibial spacer plate, showing the angle of the aligned foot relative to the supporting surface.

[0018] Figure 3 yes Figure 1 A top view of the tibial septum, showing the location of the alignment groove.

[0019] Figure 4A yes Figures 1 to 3 A side view of the tibial septum, which is inserted between the resected tibia and the resected femur at approximately sixty degrees of flexion.

[0020] Figure 4B yes Figure 4A A posterior view of the tibial septum, showing the alignment of the lateral leg with the resected surface of the femur.

[0021] Figure 4C yes Figure 4A A side view of the tibial septum, showing the tibia in full extension.

[0022] Figure 4D yes Figure 4C Anterior perspective view of the tibial septum, showing the natural rotation of the tibia.

[0023] Figure 4E yes Figure 4D Anterior perspective view of the tibial septum, with markings indicating the excised tibial surface at the alignment groove.

[0024] Figure 4F yes Figure 4E An anterior perspective view of the removed tibia, showing the marked surface of the removed tibia.

[0025] Figure 5 It is a perspective view of the tibial septum with alignment pins and alignment grooves.

[0026] Figure 6 yes Figure 5 A top view of the tibial septum, showing the location of the alignment groove.

[0027] Figure 7 yes Figure 5A perspective view of the tibial septum and the femoral component engaging with the alignment post.

[0028] Figure 8A yes Figure 7 The femoral component attached to the removed femur, and Figure 5 A perspective view of the femoral component inserted at approximately sixty degrees and the tibial spacer plate removed between the tibia.

[0029] Figure 8B yes Figure 8A A side view of the femoral component and tibial septum, moved toward a fully extended state, such that the alignment pin is aligned with the corresponding port in the femoral component.

[0030] Figure 8C yes Figure 8B A perspective view of the femoral component and tibial septum in full extension, with the tibia rotated to a natural alignment position so that the resected tibial surface can be marked at the alignment groove.

[0031] Figure 9A It is a perspective view of the femoral component attached to the removed femur and the tibial size adjustment system, which includes a temporary component and a size adjustment plate for insertion onto the removed tibia.

[0032] Figure 9B yes Figure 9A A perspective view of the femoral component and tibial size adjustment system, wherein the tibial size adjustment system is inserted between the femoral component and the resected tibia.

[0033] Figure 9C yes Figure 9B A perspective view of the femoral component and tibial size adjustment system, wherein the femur is in full extension and the tibia is rotated so that the pins extending into the femoral component are aligned with the alignment tabs on the temporary tibial component.

[0034] Figure 9D yes Figure 9B A perspective view of the femoral component and tibial size adjustment system, in which pins extend along alignment tabs and alignment marks on the tibia.

[0035] Figure 9E yes Figure 9D A perspective view of the removed tibia, showing the size adjustment plate of the tibia size adjustment system set on the surface of the removed tibia.

[0036] Figure 10 yes Figure 9A A perspective view of another embodiment of the tibial size adjustment system, in which temporary components and size adjustment plates are integrated into a single unit.

[0037] Figure 11It is a perspective view of a femoral component attached to the removed femur and a tibial size adjustment system, which includes a temporary component and a tibial plate having a pivot mount inserted between the femoral component and the removed tibia.

[0038] Figure 12 yes Figure 11 A perspective view of the tibial plate, showing the pivot mount including the bolus.

[0039] Figure 13 yes Figure 11 A top perspective view of the temporary component, showing the alignment tabs.

[0040] Figure 14 yes Figure 11 A bottom perspective view of the temporary component, showing the cutouts on the mating surfaces.

[0041] Figure 15A yes Figure 11 A perspective view of the femoral component attached to the removed femur and the tibial size adjustment system separated from the removed tibia.

[0042] Figure 15B It is the assembled Figure 15A A perspective view of a tibial size adjustment system inserted between a femoral component and the resected tibia, wherein the tibia is rotated to natural alignment such that a pin extending from the femoral component aligns with an alignment tab on a temporary component.

[0043] Figure 15C yes Figure 15B A perspective view of the tibia in full extension, with the pin fully positioned in the alignment tab, and the removed tibia marked with alignment marks.

[0044] Figure 16 yes Figure 13 and Figure 14 A top perspective view of another embodiment of the temporary component, which is not aligned with the tabs.

[0045] Figure 17 yes Figure 16 A bottom perspective view of an implementation of a temporary component without aligned tabs. Detailed Implementation

[0046] Figure 1 This is a perspective view of the tibial septum 10, which has alignment feet 12A and 12B disposed in the septum block 16 and alignment groove 14. Figure 2 yes Figure 1 A side view of the tibial spacer 10, showing the angles of the aligned feet 12A and 12B relative to the support surface 18A. Figure 3 yes Figure 1A top view of the tibial septum, showing the location of the alignment groove 14. Also discussed... Figures 1 to 3 .

[0047] The spacer block 16 may include a first support surface 18A, a second support surface 18B, an edge peripheral surface 20, a notch 22, and a handle 24. The edge peripheral surface 20 may include chamfers 26A and 26B, respectively, opposite to the alignment feet 12A and 12B. The notch 22 and the alignment groove 14 may extend into the spacer block 16 to form a first section 28A and a second section 28B. The handle 24 may extend from the edge peripheral surface 20 of the spacer block 16 and may include a first segment 30A and a second segment 30B.

[0048] The spacer 16 is configured to be inserted or otherwise positioned between the surfaces of the tibia and femur, particularly between the resected surfaces of the tibia and femur, such as... Figures 4A to 4E As shown. The first support surface 18A can be configured to face the tibia, and the second support surface 18B can be configured to face the femur. The first portion 28A and the second portion 28B can be configured to align with the condyles of the femur. The peripheral edge surface 20 can be shaped such that the first portion 28A and the second portion 28B can engage the medial and lateral condyles of the left and right femurs. In other examples, the spacer 16 can be specifically configured for either the left or right knee joint. Reference will be made below. Figures 4A to 4F As discussed in more detail, the alignment groove 14 can provide indication of rotational alignment between the tibia and femur as the tibia moves through extension and flexion, thus providing alignment information for implanting the prosthetic femoral and tibial components.

[0049] Alignment feet 12A and 12B may be located at the edges of the first section 28A and the second section 28B of the support surface 18A, respectively, so as to extend from the peripheral surface 20. In the example, alignment feet 12A and 12B are positioned posterior to the tibia and femur. Chamfers 26A and 26B are provided in the support surface 18B opposite to feet 12A and 12B, respectively, and chamfers 26A and 26B remove a portion of the spacer block 16 at the peripheral surface 20 so that the tibia can rotate against the second support surface 18B. Notch 22 may extend between the first section 28A and the second section 28B to provide visibility of the tibia. In one example, chamfers 26A and 26B may form an angle θ1 of approximately 135 degrees with the support surface 18B. Figure 2 ).

[0050] Handle 24 may extend from peripheral surface 20 to provide a structure for the surgeon to hold and manipulate spacer 16. Handle 24 may extend from the anterior portion of spacer 16 so that tibial spacer 10 can be inserted into an anterior incision of the knee joint. If necessary, instruments such as retractors may be used to hold the tibial T and femoral F in a retracted position to allow insertion of tibial spacer 10. Handle 24 may extend from peripheral surface 20, offset from the center of spacer 16, to provide space for placement of alignment groove 14, which may be positioned at the center of spacer 16. A first segment 30A of handle 24 may extend from a second portion 28B of spacer 16 at a rear end 32A. The first segment 30A may be curved toward alignment groove 14 so that the front end 32B is closer to alignment groove 14. A second segment 30B may be attached to the front end 32B so that the second segment 30B is substantially aligned with alignment groove 14. The front end 32B may be planar and may extend parallel to alignment groove 14. The second segment 30B may include an elongated body having a central axis A1 configured to extend axially in the direction of the alignment groove 14. Thus, the handle 24 provides an indication of the center of the spacer 16 and points in the direction of the alignment groove 14, providing the surgeon with a tactile indication for orientation of the tibial spacer 10. The second segment 30B may include access holes 34A and 34B capable of providing various functions, such as allowing insertion of tools or instruments through the handle 24.

[0051] Support surface 18A can be configured to face the surface of the resected tibia. Support surface 18B can be configured to face the surface of the resected femur. The surfaces of the resected tibia and femur can be planar or nearly planar. Support surfaces 18A and 18B can also be planar or nearly planar to facilitate sliding against the surfaces of the resected tibia and femur. Alignment groove 14 can extend from the first support surface 18A through the spacer 16 to the second support surface 18B, allowing access to the resected tibia via alignment groove 14. Alignment groove 14 can taper between the first support surface 18A and the second support surface 18B. Alignment groove 14 can be wider at the first support surface 18A than at the second support surface 18B. Thus, the indicating surface can be configured to guide instruments such as pens, electrocautery devices, markers, scalpels, or picks toward the tibia. The greater width of the alignment groove 14 at the first support surface 18A facilitates the surgeon's insertion of the instrument into the alignment groove 14, while the narrower width of the alignment groove 14 at the second support surface 18B facilitates the guidance of the instrument to a more precise position on the tibia.

[0052] Alignment feet 12A and 12B can be configured to retain spacer 16 in contact with the resected femur. Posterior surfaces 36A and 36B can extend from the first support surface 18A at a right angle or near a right angle. However, in other examples, posterior surfaces 36A and 36B can extend at other angles relative to support surface 18A for surgical procedures where the surface of the resected femur is not perpendicular to the resected flat anterior surface of the femur (e.g., ...). Figure 4A (As shown). Therefore, the supporting surface 18A can remain engaged with the distal resected surface of the femur, while the posterior surfaces 36A and 36B can remain engaged with the posterior resected surface of the femur. If necessary, the surgeon can grasp the handle 24 to facilitate engagement between the spacer block 16 and the femur. As the tibia moves from a flexed to an extended position, the tibia can rotate along the vertical axis A2 against the supporting surface 18B, as shown in the reference. Figures 4A to 4F A more detailed description.

[0053] Figure 4A yes Figures 1 to 3 A lateral view of the tibial spacer 10, inserted between the resected tibia T and the resected femur F, flexed at approximately sixty degrees as defined by angle θ2. The resected tibia T may include a proximal surface S1. The resected femur F may include a distal surface S2, a first posterior surface S3A, a second posterior surface S3B, an angled anterior surface S4, a first quarter surface S5A, and a second quarter surface S5B. The tibia T and femur F can be removed using any conventional resection procedure. Figures 1 to 3 The tibial septum 10 depicted in the image is configured to... Figures 4A to 4F The resected surface shown is used in conjunction with the resected portion. However, the tibial septum 10 can also be used with other resected portions. Additionally, the tibial septum 10 can be modified for use with other resected portions. In various embodiments, the tibial septum 10 can be configured to allow one of the tibia T and femur F to rotate against the tibial septum 10 while having a surface that allows the tibial septum 10 to remain flush with the other of the tibia T and femur F.

[0054] With the tibia T and femur F in a flexed position, the tibial spacer 10 can be inserted between the distal surface S2 of the femur F and the proximal surface S1 of the tibia T. For example, the tibia T and femur F can be positioned with approximately 60 degrees of flexion to receive the tibial spacer 10, as defined by the angle θ2 between the femoral axis AF and the tibial axis AT. The surgeon can grasp the handle 24 to insert the spacer 16 into the incision of the patient's knee joint and further into the space between the tibia T and femur F. Alignment feet 12A and 12B can slide around the distal surface S2 to engage the first posterior surface S3A and the second posterior surface S3B. Support surface 18A can be positioned against the distal surface S2. Chamfers 26A and 26B can be positioned to contact the proximal surface S1. In the case where the femur F and tibia T are set with 60 degrees of flexion, as Figure 4A As shown, chamfers 26A and 26B will be slightly inclined relative to the proximal surface S1, such that chamfers 26A and 26B engage with the edge of the peripheral surface 20 and the proximal surface S1. In other words, if the femur F and tibia T are set to flex at 45 degrees, chamfers 26A and 26B will be flush with the proximal surface S1 due to the angle θ1 being 135 degrees.

[0055] Figure 4B yes Figure 4A A posterior view of the tibial septum 10 shows aligned legs 12A and 12B engaging with the first posterior surface S3A and the second posterior surface S3B of the femur F. A notch 22 is shown between legs 12A and 12B, and a proximal surface S1 is shown between them. A supporting surface 18A is shown engaging with the distal surface S2. Thus, legs 12A and 12B can rotate on the proximal surface S1 when the tibia T and femur F move between extension and flexion, and when the tibia T rotates relative to the femur F. The tibial septum 10 can remain engaged with the tibia T due to the pressure exerted by the tendons and ligaments connecting the tibia T and femur F.

[0056] Figure 4C yes Figure 4A A side view of the tibial septum 10, showing the tibia T1 in full extension. When the tibia T1... Figure 4BWhen the tibial spacer 10 moves from its flexed position to its fully extended position, the tibia rotates such that the supporting surface 18B engages with the proximal surface S1 of the tibia. With the supporting surface 18A already flush with the distal surface SS, the spacer block 16 can be squarely positioned between the distal surface S2 and the proximal surface S1. The legs 12A and 12B maintain the rotational orientation of the tibial spacer 10 relative to the axis of the femur F, thereby allowing the tibia to rotate along its axis against the supporting surface 18B when the tibia moves to its extended position. The alignment groove 14 points to a portion of the tibia, indicating the position of the center of the femur F pointing towards the proximal surface S1, thus showing the natural rotational position of the tibia relative to the femur F.

[0057] The spacer 16 may have a thickness between the support surfaces 18A and 18B, which can be matched to various prosthetic devices. For example, this thickness may be equal to the total thickness of the femoral and tibial components used for implantation of the femoral F and tibial T, respectively. The thickness of the spacer 16 allows the ligaments and tendons of the femoral F and tibial T to hold the spacer 16 under the natural tension of the knee joint. Different tibial spacers 10 may be configured with different thicknesses to allow surgeons to test different prosthetic devices with desired tension levels in the knee joint.

[0058] Figure 4D yes Figure 4C The anterior perspective view of the tibial spacer 10 shows the natural rotation of the tibia T. As mentioned, with the support surface 18A flush with the distal surface S2 of the femur F and the support surface 18B flush with the proximal surface S1 of the tibia T, the tibia T can rotate freely against the spacer 16, as indicated by rotation arrows R1 and R2. The resected surface S4 of the femur F allows access to the alignment groove 14 for visual inspection and insertion of tools or instruments.

[0059] Figure 4E yes Figure 4D An anterior perspective view of the tibial septum 10, in which the mark 38 of the removed tibial surface is located at the alignment groove 14. Except that the rotation arrows R1 and R2 are removed and the mark 38 is shown on the proximal surface S1 within the boundary of the alignment groove 14, Figure 4E and Figure 4D same. Figure 4F yes Figure 4E Anterior perspective view of the resected tibia T, showing the proximal surface S1 including marker 38. Figure 4F It shows the relationship with Figure 4E Tibial T with the same orientation, but without tibial septum 10.

[0060] Alignment groove 14 can be aligned with the center of the femur F, for example, the center position between the medial and lateral condyles that coincides with the femoral axis AF. However, the tibia T can be oriented away from the femur F such that the center of the tibia T that coincides with the tibial axis AT is not aligned with the center of the femur F. The tibial spacer 10 includes alignment groove 14 to allow the surgeon to see and mark the rotational position of the center of the femur F relative to the tibia T in order to prepare the tibia T and femur F for implantation of the prosthetic knee device. Instruments or tools such as pens, electrocautery devices, markers, scalpels, or excision tools can be inserted into alignment groove 14 on the support surface 18A and pushed through alignment groove 14 to penetrate the support surface 18B and contact the proximal surface S1 of the tibia T.

[0061] Marking 38 may include an ink strip from a marker, markings in the proximal surface S1 from an excavator, etc. Marking 38 can provide a fixed indicator on the proximal surface S1, indicating the alignment of the center of the femur F with the tibia T. Therefore, the center of the prosthetic tibial implant to be attached to the proximal surface S1 of the tibia T can be aligned with marking 38 during implantation. Thus, for example, the support surface of the prosthetic tibial implant, configured to mate with the condylar surface of the prosthetic femoral implant to be attached to the femur F, can be oriented such that the tibia T will have a natural rotational orientation in full extension. When correctly aligned in extension, the prosthetic femoral and tibial components will not resist the natural orientation of the knee joint, and joint pain and discomfort can be avoided.

[0062] The tibial septum 10 provides passive engagement with the distal surface S2 of the femur F. The tibial septum 10 is held in frictional engagement with the femur F by means of legs 12A and 12B. Other embodiments of the tibial septum may include features for providing active engagement with the femur F.

[0063] Using the above-described apparatus and procedures, a method for determining rotation between the femur and tibia may include the following steps: removing the femur and tibia; positioning the tibia in approximately 60 degrees of flexion; inserting a tibial septum into an anterior opening between the resected portions of the tibia and femur; engaging the medial and lateral septum appendages to the posterior surface of the femur, thereby connecting the tibial septum to the femur; extending the tibia to an extended position so that the tibia can rotate against the tibial septum; assessing the articular tension between the tibia and femur; inserting tibial septums of varying thicknesses into the anterior opening until the desired articular tension is achieved; ensuring that the medial and lateral septum appendages engage the posterior surface of the femur to allow the tibia to rotate against the tibial septum to a natural position; identifying the center of the femur at an alignment groove in the center of the tibial septum; and marking the center of the femur on the tibia using the alignment groove.

[0064] Figure 5This is a perspective view of the tibial septum 110, which has alignment posts 112A and 112B disposed in the septum block 116 and alignment groove 114. Figure 6 yes Figure 5 A top view of the tibial septum 110, showing the position of the alignment groove 114 relative to the support surface 118A. (Discussion follows.) Figure 5 and Figure 6 Alignment posts 112A and 112B can be configured to provide active engagement with the femoral prosthesis component attached to the femur F.

[0065] Spacer 116 may include a first support surface 118A, a second support surface 118B, a peripheral edge surface 120, a notch 122, and a handle 124. Spacer 116 may have a thickness between support surfaces 118A and 118B, which may vary in different embodiments to test tension in the knee joint. Since spacer 116 is configured to mate with femoral component 240, spacer 116 may typically be thinner than spacer 16. Peripheral edge surface 120 may include edge chamfers 126A and 126B. Notch 122 and alignment groove 114 may extend into spacer 116 to form a first condylar portion 128A and a second condylar portion 128B. Handle 124 may extend from peripheral edge surface 120 of spacer 116 and may include a first segment 130A and a second segment 130B. The second segment 130B may include an elongated body having a central axis A3 configured to extend axially in the direction of the alignment groove 114.

[0066] Except that the outriggers 12A and 12B are replaced by alignment posts 112A and 112B, and the chamfers 26A and 26B are replaced by edge chamfers 126A and 126B, the tibial septum 110 and Figures 1 to 3 The tibial septum 10 is constructed similarly. Additionally, the posterior surfaces 36A and 36B are replaced by the proximal surfaces 136A and 136B. All other elements are similarly numbered in the 100 series.

[0067] Alignment posts 112A and 112B can be configured to retain spacer 116 with femoral implant 140 attached to the removed femur. Figure 7 The proximal surfaces 136A and 136B may protrude or project from the first support surface 118A, such that the studs 112A and 112B are perpendicular to the support surface 118A. However, in other examples, the proximal surfaces 136A and 136B may extend at other angles relative to the support surface 118A for use with... Figure 7The femoral implant shown is a different type of femoral implant. Therefore, when the knee joint moves through flexion, the alignment posts 112A and 112B can remain engaged with the femoral component 140. If necessary, the surgeon can grasp the handle 124 to facilitate engagement of the spacer block 116 with the femur. When the tibia moves from a flexed to an extended position, the tibia can rotate against the support surface 118B along the vertical axis A4, as shown in the reference. Figures 8A to 8C A more detailed description.

[0068] Figure 7 yes Figure 5 A perspective view of the tibial septum 110 and the femoral component 140 engaging with alignment posts 112A and 112B. The femoral component 140 may include a femoral specimen component having a distal surface for engaging the tibial component and a proximal surface for engaging the resected femur. Multiple femoral components may be configured such that each femoral component has different parameters, such as thickness, varus / valgus angle, etc., to suit the patient's anatomy. The femoral component 140 may be held in place against the femur F using bone cement, fasteners, or by force fit with the resected surface.

[0069] The femoral component 140 may include a tibial surface 142 formed along the outer periphery of the femoral component 140, and may include a first condyle 144A and a second condyle 144B. The first condyle 144A and the second condyle 144B may be configured to articulate with a prosthetic tibial component. The femoral component 140 may include an anterior flange 146 having a trochlear groove 148. The trochlear groove 148 may extend from a generally anterior and proximal origin to a generally posterior and distal end. The trochlear groove 148 may form the anterior articular surface of the femoral component 140 for articulation with a natural or prosthetic patella.

[0070] The femoral component 140 may define a transverse plane, which may be a plane tangent to the farthest points of the first condyle 144A and the second condyle 144B. The femoral component 140 may also define a coronal plane, which, when viewed from the side of the femoral component 140, may be a plane tangent to the furthest points of the first condyle 144A and the second condyle 144B, and may be perpendicular to the transverse plane.

[0071] The femoral component 140 may include stud ports 150A and 150B, which may be configured to engage and align studs 112A and 112B, respectively. Stud ports 150A and 150B may be positioned in a transverse plane at the most distal points of the first condyle 144A and the second condyle 144B, respectively.

[0072] The femoral component 140 may include a femoral contact portion 152 formed along the inner periphery of the femoral component 140, and may include a distal surface 154, a first posterior surface 156A, a second posterior surface 156B, an angled anterior surface 158, a first quarter surface 160A, and a second quarter surface 160B. The distal surface 154, the first posterior surface 156A, the second posterior surface 156B, the angled anterior surface 158, the first quarter surface 160A, and the second quarter surface 160B may be configured to respectively contact with... Figures 4A to 4F The distal surface S2, the first posterior surface S3A, the second posterior surface S3B, the angled anterior surface S4, the first quarter surface S5A, and the second quarter surface S5B of the tibia T are aligned and fitted together.

[0073] Figure 8A yes Figure 7 A perspective view of the femoral component 140, which is attached to the resected femur F and Figure 5 The tibial septum 110 is inserted between the femoral component 140, which is flexed at approximately sixty degrees, and the resected tibial T.

[0074] With the knee joint in a flexed position, the tibial septum 110 can be inserted into an incision at the anterior aspect of the knee joint, allowing the handle 124 to extend out of the incision. The second support surface 118B can be positioned against the resected proximal surface S1. The femur F and tibia T of the knee joint can be pushed or pulled apart, for example, by using a retractor, to provide space for the tibial septum 110. Edge chamfers 126A and 126B facilitate the insertion of the tibial septum 110 by narrowing the septum block 116 and eliminating sharp edges that could interfere with or damage the knee ligaments. The tibial septum 110 can be positioned such that the alignment posts 112A and 112B are aligned with the post ports 150A and 150B in the femoral component 140, respectively.

[0075] Figure 8B yes Figure 8A A side view of the femoral component 140 and tibial septum 110 shows the femoral component 140 and tibial septum 110 moving toward full extension, such that alignment posts 112A and 112B are aligned with and inserted into corresponding post ports 150A and 150B in the femoral component 140. When the tibia T is moved to the extended position as indicated by arrow E, the surgeon can use handle 124 to guide the alignment posts 112A and 112B into the post ports 150A and 150B. When the posts 112A and 112B engage the femoral component 140, the proximal surface S1 of the tibia T can slide against the support surface 118B, and the tibia T rotates naturally into the extended position.

[0076] Figure 8C yes Figure 8B A perspective view of the femoral component 140 and tibial septum 110 in full extension, with the tibia T rotated to its natural alignment position so that the resected proximal surface S1 can be marked at the alignment groove 114. With support surface 118A flush with the femoral component 140 and support surface 118B flush with the proximal surface S1 of the tibia T, the tibia T can rotate freely against the septum 116, as indicated by rotation arrows R3 and R4. Studs 112A and 112B hold the tibial septum 110 in active engagement with the femoral component 140 at stud ports 150A and 150B. This engagement reduces or eliminates slippage of the tibial septum 110 relative to the femur F, which helps provide an accurate indication of the natural rotational position of the tibia T relative to the femur F in extension. Alignment groove 114 can be seen between the first condyle 144A and the second condyle 144B of the femoral component 140 for visual inspection and insertion of tools or instruments.

[0077] Mark 138 may include an ink strip from a marker, a notch in the proximal surface S1 from a pickup, etc. Mark 138 provides a fixation indicator on the proximal surface S1 pointing to the alignment of the center of the femur F with the tibia T. Therefore, the center of the prosthetic tibial implant to be attached to the proximal surface S1 of the tibia T can be aligned with mark 138 during implantation.

[0078] Using the above-described apparatus and procedures, a method for determining rotation between the femur and tibia may include the following steps: removing the femur and tibia; positioning the tibia in approximately 60 degrees of flexion; attaching a femoral component to the removed femur; inserting a tibial septum into an anterior opening between the tibial and femoral resection portions; guiding the tibial septum's studs to corresponding ports in the femoral component to connect the tibial septum and femoral component; extending the tibia to an extended position so that the tibia rotates against the tibial septum; assessing the articular tension between the tibia and femur; inserting tibial septums of varying thicknesses into the anterior opening until the desired articular tension is achieved; allowing the tibia to rotate against the tibial septum to a natural position; identifying the center of the femur at an alignment groove in the center of the tibial septum; and marking the center of the femur on the tibia using the alignment groove.

[0079] Figure 9AThis is a perspective view of a tibial size adjustment system 210, which includes a temporary component 212 and a size adjustment plate 214, aligned for insertion onto the removed tibial T. The temporary component 212 may include condylar support surfaces (or articular connection surfaces) 216A and 216B, an opposing engagement (support) surface 218, a slot 220, and an alignment tab 222. The alignment tab 222 may include a body 224 and a notch 226. The size adjustment plate 214 may include a bone engagement surface 228, an engagement surface 230, a slot 232, and etched lines 234A and 234B. (Reference) Figure 9E Further discussion is given of the sizing adjustment plate 214. In the example, temporary component 212 may include a one-piece tibial articular surface temporary component (TASP), commercially available from the Persona brand of Zimmer Biomet, modified to include alignment tabs 222. In the example, sizing adjustment plate 214 may include a tibial sizing adjustment plate as described in U.S. Patent No. 5,634,927 to Houston et al., which is owned by Zimmer Corporation, modified to include etched lines 234A and 234B. The entire contents of U.S. Patent No. 5,634,927 to Houston et al. are incorporated herein by reference for all purposes.

[0080] Figure 9A A femoral component 240 attached to the removed femur F is also shown. Except for the addition of a pin port 262, the femoral component 240 can be similar to... Figure 7 The femoral component 140. All other components are numbered similarly to those in the 200 series. For example, the femoral component 240 may include a tibial-facing surface 242 formed along the outer periphery of the femoral component 240, which may include a first condyle 244A and a second condyle 244B, an anterior flange 246 having a trochlear groove 248, and a femoral contact portion 252 formed along the inner periphery of the femoral component 240, the femoral contact portion 252 including a distal surface, a first posterior surface, a second posterior surface, an angled anterior surface, a first quarter surface, and a second quarter surface.

[0081] The femoral component 240 may also include a pin port 262 for receiving a pin 264. A pin 264, such as a cannula, can be inserted into the pin port 262. When the center of the femoral component 240 is aligned with the temporary component 212, the pin port 262 can be positioned to align with the alignment tab 222.

[0082] As described above, the femoral component 240 can be attached to the femur F in any suitable manner. Similarly, the temporary component 212 can be releasably attached to the size adjustment plate 214. For example, the temporary component 212 can snap-fit ​​with the size adjustment plate 214 as described below. The size adjustment plate 214 is configured to slide against the proximal surface S1 of the tibia T. Since the femoral component 240 and the tibial temporary component 212 can be configured as trial components, the femoral component 240 and the temporary component 212 can be removably attached to their respective surfaces.

[0083] exist Figure 9A In this process, the tibial T and femoral F can be removed to achieve the desired appearance as shown in the reference. Figure 4A The surface described. The femoral component 240 can be attached to the femur F, and then the tibial size adjustment system 210 can be inserted between the femoral component 240 and the proximal surface S1 of the resected tibia T, as indicated by arrow I1.

[0084] Figure 9B yes Figure 9A A perspective view of the femoral component 240 and the tibial size adjustment system 210, wherein the tibial size adjustment system 210, inserted between the femoral component 240 and the resected tibia T, is in an extended state. As shown, the pin port 262 and the alignment tab 222 are located on the same side of the femoral component 240 and the tibial size adjustment system 210, respectively. When the tibia T is moved to a fully extended state, the size adjustment system 210 can be positioned such that the notch 226 can be aligned with the pin 264 when the proximal surface S1 of the tibia T rotates against the bone engagement surface 228 of the size adjustment plate 214. With the pin 264 engaging the notch 226, the temporary component 212 can be replaced with a temporary component with a similar structure but a different thickness. For example, in different embodiments of the size adjustment plate 214, the thickness between the support surfaces 216A and 216B and the engagement surface 218 can be different. Different thicknesses can be used to set the desired ligament tension between the tibia T and the femur F.

[0085] Figure 9C yes Figure 9B A perspective view of the femoral component 240 and the tibial size adjustment system 210, wherein the femur F is in full extension and the tibia T is rotated such that a pin 264 extending into the femoral component 240 is aligned with an alignment tab 222 on the temporary tibial component 212. After the desired tension is set, the tibia T and femur F can be set in an extended state such that the pin 264 is aligned with a notch 226. As indicated by the rotation arrows R5 and R6, the tibia T can find a natural rotational position relative to the femur F in the extended state. For example, the proximal surface S1 of the tibia T can rotate against the bone-jointing surface 228 of the size adjustment plate 214.

[0086] Figure 9Dyes Figure 9B A perspective view of the femoral component 240 and the tibial size adjustment system 210, wherein pins 264 extend along alignment tabs 222, and alignment marks 266A and 266B are on the tibial T. Etched lines 234A and 234B may be positioned adjacent to the proximal surface S1 along the tibial T. Markers 266A and 266B may include ink strips from a pen, an electrocautery device, a marker, or engravings in the surface of the proximal surface S1 from a digger, etc. Markers 266A and 266B provide fixation indicators on the proximal surface S1, indicating the location of the center of the femoral F and a secondary reference point on the tibial T. For example, mark 266B may indicate the center of the femoral F, and mark 266A may be used to verify rotation of the tibial T and provide a secondary reference point. In this way, the center of the prosthetic tibial implant to be attached to the proximal surface S1 of the tibia T can be aligned with mark 266B during implantation, and the secondary mark corresponding to the etched line 234A on the prosthetic tibial implant can be aligned with mark 266A.

[0087] Figure 9E yes Figure 9D A perspective view of the resected tibia T shows a size adjustment plate 214 of a tibia size adjustment system 210 disposed on the surface T of the resected tibia. The size adjustment plate 214 may include a wall 268, a keel slot 270, and a fixation hole 272. The fixation hole 272 may include an opening in a mating surface 230 into which a fastener can be inserted to hold the size adjustment plate 214 against the proximal surface S1 of the tibia T. The keel slot 270 may include an opening in the mating surface 230 into which a fixation feature (such as a keel) of a prosthetic tibia component can be inserted. The wall 268 may include a flange extending from the mating surface 230 for retaining a temporary component 212. For example, the temporary component 212 may include a corresponding feature allowing the temporary component 212 to snap into the wall 268 (e.g., Figure 14 Incisions 290 and 292). Etched lines 234A and 234B and markings 266A and 266B can be used to orient the keel slot 270 relative to the proximal surface S1 to provide the mechanical axis of the prosthetic tibial component relative to the tibial T (e.g., Figure 1 The vertical axis A2 or Figure 4A The rotational orientation of the tibial axis (AT). Further description of the size adjustment plate 214 can be found in the aforementioned Houston et al. patent 5634927.

[0088] Using the above-described apparatus and procedures, a method for determining rotation between the femur and tibia may include the following steps: removing the femur and tibia; positioning the tibia in approximately 60 degrees of flexion; attaching a femoral component to the removed femur; inserting a pin into the femoral component; connecting a tibial size adjustment plate to a temporary tibial component; inserting the interconnected tibial size adjustment plate and temporary tibial component into an anterior opening between the tibial and femoral resection portions; extending the tibia to an extended position so that the tibia rotates against the tibial size adjustment plate; guiding the pin into a notch in the temporary tibial component to connect the temporary tibial component and the femoral component; assessing the joint tension between the tibia and femur; connecting temporary tibial components of varying thicknesses to the tibial size adjustment plate until the desired joint tension is achieved; rotating the tibia against the tibial size adjustment plate to a natural position; identifying the center of the femur at an indicator at the center of the tibial size adjustment plate; and marking the center of the femur on the tibia using the indicator.

[0089] Figure 10 yes Figure 9A A perspective view of another embodiment of the sizing adjustment system 210', in which the temporary component 212' and the sizing adjustment plate 214' are integrated into a single integral component 273. Besides being a single integral component, the integral component 273 can function the same as a combination of the temporary component 212 and the sizing adjustment plate 214. Therefore, multiple integral components 273 can be provided with different thicknesses to test the desired ligament tension between the tibia T and femur F. For simplicity, certain features, such as the slot 232, can be eliminated from the tibia sizing adjustment system 210'. Furthermore, the mating surfaces 218 and 230 can be eliminated because the integral component 273 is fused along the intersection of these planes compared to the tibia sizing adjustment system 210.

[0090] Using the above-described apparatus and procedures, a method for determining rotation between the femur and tibia may include the following steps: removing the femur and tibia; positioning the tibia in approximately 60 degrees of flexion; attaching a femoral component to the removed femur; inserting a pin into the femoral component; inserting a temporary tibial component into an anterior opening between the tibial and femoral resection portions; extending the tibia to an extended position so that the tibia rotates against the temporary tibial component; guiding the pin into a notch in the temporary tibial component to connect the temporary tibial component and the femoral component; assessing the articular tension between the tibia and femur; inserting temporary tibial components of varying thicknesses into the anterior opening until the desired articular tension is achieved; allowing the tibia to rotate relative to the temporary tibial component to a natural position; identifying the center of the femur at an indicator at the center of the temporary tibial component; and marking the center of the femur on the tibia using the indicator.

[0091] Figure 11This is a perspective view of the femoral component 240 attached to the removed femur F and the tibial size adjustment system 410 including the temporary component 212 and the tibial plate 300, wherein the pivot mount 302 ( Figure 12 The temporary component 212 is inserted between the femoral component 240 and the resected tibial T. The temporary component 212 may include a pivot port 274. Figure 14 It can receive a pivot mount 302, so that the temporary component 212 can rotate or pivot relative to the tibial plate 300.

[0092] As described herein, the femoral F and tibial T can be removed. The femoral component 240 can be configured to... Figures 9A to 9D The temporary component 212 is identical to the femoral component 240, except that it includes a pin port 262 for receiving a pin 264. The temporary component 212 may be similar to the temporary component 240, except that a pivot port 274 and etched lines 278A and 278B are added. Figures 9A to 9D Temporary component 212. All other components have the same number.

[0093] As described above, the pivot port 274 and the pivot mount 302 can be connected in a rotational engagement manner. The tibial plate 300 can freely engage the tibia T, and the temporary member 212 can slide against the tibial plate 300 to determine the natural rotation of the tibia T.

[0094] Figure 12 yes Figure 11 A perspective view of a tibial plate 300 having a pivot mount 302, which may be configured to extend from a support surface 304. Furthermore, the tibial plate 300 may include a bone engagement surface 306 and a peripheral edge region 308 that may connect the support surface 304 and the bone engagement surface 306. The pivot mount 302 may include a cylindrical stud extending perpendicularly from the support surface 304. The support surface 304 may have a smooth surface to reduce frictional engagement with the engagement surface 218. For example, the tibial plate 300 may be finished, such as by polishing, to reduce the coefficient of friction of the support surface 304.

[0095] Figure 13 yes Figure 11 The top perspective view of temporary component 212 shows the structure of alignment tab 222 and slot 232. Alignment tab 222 may include a body 224 and a notch 226. Slot 232 may include holes 284A and 284B and a through hole 286.

[0096] The notch 226 may include a base 280 and sidewalls 282A and 282B. The notch 226 may be configured to receive a pin, rod, or other member, such as a pin 264, extending from the femoral member 240. For example, the base 280 may form a semi-circular wall. The pin 264 may be cylindrical, and the base 280 may be configured to have a matching diameter to receive the pin 264 flush with it. The sidewalls 282A and 282B may extend upward from the base 280 away from the remainder of the body 224, and the distance between the sidewalls 282A and 282B may increase as the sidewalls 282A and 282B extend further away from the base 280. In other words, the portion of the body 224 forming the sidewalls 282A and 282B may taper as the sidewalls 282A and 282B extend away from the base 280. Thus, when the tibia T moves to its fully extended position, the wider portion of the notch 226 in the proximal direction can guide the pin 264 to engage with the base 280.

[0097] Slot 232 can be configured to receive a tool for insertion and removal of temporary component 212. In the example, holes 284A and 284B can be configured to receive a pin of a tibia insertion handle. Subsequently, through hole 286 can be configured to receive a tooth of a spring-loaded slider on the handle, which locks the handle to temporary component 212. In the example, slot 232 can be configured to work in conjunction with the pin and tooth described in U.S. Patent No. 8,603,101 to Claypool et al., the entire contents of which are incorporated herein by reference for all purposes.

[0098] Figure 14 yes Figure 11 A bottom perspective view of temporary component 212 shows mating surface 218, pivot port 274, front notch 290, and rear notch 292. The mating surface (or support surface) 218 ​​may be smooth to slide against support surface 304. Pivot port 274 may be located in mating surface 218 and may be positioned to align with pivot mount 302. Pivot port 274 may include a cylindrical hole for receiving pivot mount 302. Front notch 290 and rear notch 292 may be recesses into mating surface 218 extending to peripheral edge surface 294. Peripheral edge surface 294 may connect mating surface 218 and condyle support surfaces 216A and 216B. Peripheral edge surface 294 may also include etched lines 278A and 278B. Front notch 290 and rear notch 292 may be configured to engage the wall 268 of size adjustment plate 214. Figure 9E This helps to keep the temporary component 212 engaged with the sizing adjustment plate 214. In addition, the front cutout 290 and the rear cutout 292 allow the engagement surface 218 to sit in the wall 268.

[0099] Figure 15A yes Figure 11 A perspective view of the femoral component 240 attached to the resected femur F and the tibial size adjustment system 410 separated from the resected tibia T. As shown by arrow C1, by inserting the pivot mount 302 into the pivot port 274 ( Figure 14 In this arrangement, the tibial plate 300 can be connected to the temporary component 212 to form the assembled tibial size adjustment system 410. A biocompatible lubricant can be placed between the tibial plate 300 and the temporary component 212 to facilitate relative rotation between them. As indicated by arrow C2, the assembled tibial size adjustment system 210 can be inserted into the knee joint between the tibia T and femur F, such that surface 306 faces the proximal surface S1 of the tibia T. Thus, support surfaces 216A and 216B can face the femoral component. Different temporary components 212 of varying thicknesses can be tried between the tibia T and femur F to find the appropriate tension.

[0100] Figure 15B yes Figure 15A A perspective view of the assembled tibial size adjustment system 410, inserted between the femoral component 240 and the resected tibia T. A pin 264 can be inserted into the pin port 262 of the femoral component 240. When the pin 264 engages with the alignment tab 222 to lock relative rotation between the femoral component 240 and the temporary component 212, the tibia T can rotate to natural alignment, as indicated by rotation arrows R7 and R8, with the proximal surface S1 rotating against surface 306. The tibial plate 300 is attached to the temporary component 212 via a pivot mount 302, which allows the tibial plate 300 to slide against the proximal surface S1 as the tibia T rotates, providing better indication of the natural rotational position of the tibia T relative to the femur F in extension. For example, the tibia T can be less hindered by resistance from the tibial size adjustment system 410 to facilitate true rotation of the tibia T.

[0101] Figure 15C yes Figure 15B A perspective view of the tibia T in its fully extended state, such that pin 264 is fully positioned in alignment tab 222, and the resected tibia T is marked with alignment marks 310A and 310B. Like marks 266A and 266B, marks 310A and 310B provide reference marks for alignment with features of the prosthetic tibial component that provide rotational alignment of the prosthetic tibial component, such that the prosthetic tibial component does not exert stress on the knee joint when in extension; for example, the tibia T will find its natural rotational position without any back thrust from the prosthetic tibial component against the prosthetic femoral component. In various examples, the tibial plate 300 may include an incision or window (not shown) allowing observation of the proximal surface S1 through the tibial plate 300.

[0102] Using the above-described apparatus and procedures, a method for determining rotation between the femur and tibia may include the following steps: removing the femur and tibia; positioning the tibia in approximately 60 degrees of flexion; attaching a femoral component to the removed femur; inserting a pin into the femoral component; connecting a tibial plate to a temporary tibial component at a pivot connection; inserting the connected tibial plate and temporary tibial component into an anterior opening between the tibial and femoral resection portions; extending the tibia to an extended position so that the tibia rotates against the tibial plate; guiding the pin into a notch in the temporary tibial component to connect the temporary tibial component and the femoral component; assessing the articular tension between the tibia and femur; connecting temporary tibial components of varying thicknesses to the tibial plate until the desired articular tension is achieved; allowing the tibia to rotate against the temporary tibial component to its natural position when rotating against the temporary tibial component; identifying the center of the femur at an indicator at the center of the temporary tibial component; and marking the center of the femur on the tibia using the indicator.

[0103] Figure 16 yes Figure 13 and Figure 14 A top perspective view of another embodiment of the temporary component 212, but without aligning the tab 222. Figure 17 yes Figure 16 A bottom perspective view of an embodiment of the temporary component 212. The alignment tab 222 can be omitted to simplify the construction of the temporary component 212 and the method of using the tibial component. In some cases, it is sufficient to determine the natural rotational position of the tibia T without preventing relative rotation between the femoral component 240 and the temporary component 212. For example, frictional engagement between the first condyle 244A and the second condyle 244B and the support surfaces 216A and 216B, respectively, may be sufficient to secure the temporary component 212. In this example, the support surfaces 216A and 216B may be textured, such as knurled, pyramidal, spiked, or other protrusions, to facilitate associated rotation.

[0104] Using the above-described apparatus and procedures, a method for determining rotation between the femur and tibia may include the following steps: removing the femur and tibia; positioning the tibia in approximately 60 degrees of flexion; attaching a femoral component to the removed femur; connecting a tibial plate to a temporary tibial component at a pivot joint; inserting the connected tibial plate and temporary tibial component into an anterior opening between the tibial and femoral resection portions; extending the tibia to an extended position so that the tibia rotates against the tibial plate; assessing the articular tension between the tibia and femur; connecting temporary tibial components of varying thicknesses to the tibial plate until the desired articular tension is achieved; allowing the tibia to rotate to its natural position against the tibial plate as it rotates against the temporary tibial component; identifying the center of the femur at an indicator at the center of the temporary tibial component; and marking the center of the femur on the tibia using the indicator.

[0105] Various notes and examples

[0106] Example 1 may include or use a subject such as a tibial spacer, which may include: a spacer block that may include: a first support surface, a second support surface disposed opposite to the first support surface, and an edge peripheral region connecting the first support surface and the second support surface; a first leg extending from the first support surface at the edge peripheral region; a second leg extending from the first support surface at the edge peripheral region spaced apart from the first leg at the edge peripheral region; a first alignment chamfer extending into the edge peripheral region and the second support surface opposite to the first leg; a second alignment chamfer extending into the edge peripheral region and the second support surface opposite to the second leg; an alignment groove extending into the edge peripheral region opposite to the first and second legs; and a handle extending from the spacer block.

[0107] Example 2 may include, or optionally combine with the subject of Example 1, to optionally include, an alignment slot that can be positioned between the first and second legs.

[0108] Example 3 may include, or optionally combine with the subject matter of one or any combination of Examples 1 or 2, to optionally include a notch extending into the periphery region of the edge between the first and second aligned chamfers.

[0109] Example 4 may include, or optionally combine with the subject matter of one or any combination of Examples 1 to 3, to optionally include, notches that can be aligned with the alignment groove on opposite sides of the spacer block.

[0110] Example 5 may include, or optionally combine with the subject matter of one or any combination of Examples 1 to 4, to optionally include recesses and alignment grooves that divide the first support surface into first and second condylar surfaces.

[0111] Example 6 may include, or optionally combine with the subject matter of one or any combination of Examples 1 to 5, to optionally include, first and second alignment chamfers that may be set at approximately forty-five degrees relative to the first and second support surfaces.

[0112] Example 7 may include, or optionally combine with the subject matter of one or any combination of Examples 1 to 6, to optionally include, an alignment groove that tapers between the first support surface and the second support surface.

[0113] Example 8 may include, or optionally combine with, the subject of one or any combination of Examples 1 to 7 to optionally include a handle that may extend from the peripheral area of ​​the edge near the alignment slot.

[0114] Example 9 may include, or optionally combine with, the subject matter of one or any combination of Examples 1 to 8 to optionally include a handle comprising: a curved segment extending from a peripheral edge region; and a straight segment connected to the curved segment.

[0115] Example 10 may include, or may optionally be combined with the subject matter of one or any combination of Examples 1 to 11, to optionally include a curved segment that can be positioned as a straight segment aligned with an alignment groove.

[0116] Example 11 may include or use a subject such as a tibial spacer system, which may include: a spacer block that may include: a first support surface, a second support surface disposed opposite to the first support surface, and an edge peripheral region connecting the first support surface and the second support surface; a first stud extending from the first support surface; a second stud extending from the first support surface spaced apart from the first stud; an alignment groove extending into the edge peripheral region; and a handle extending from the spacer block.

[0117] Example 12 may include, or optionally combine with the subject matter of Example 11, to optionally include, an alignment groove that can be positioned between the first and second studs.

[0118] Example 13 may include, or optionally combine with, the subject matter of one or any combination of Examples 11 or 12 to optionally include, a notch extending into the peripheral region of the edge between the first and second studs.

[0119] Example 14 may include, or optionally combine with the subject matter of one or any combination of Examples 11 to 13, to optionally include, notches that can be aligned with the alignment groove on opposite sides of the spacer block.

[0120] Example 15 may include, or optionally combine with the subject matter of one or any combination of Examples 11 to 14, to optionally include recesses and alignment grooves that divide the first support surface into first and second condylar surfaces.

[0121] Example 16 may include, or optionally combine with the subject matter of one or any combination of Examples 11 to 15, to optionally include, a first post and a second post spaced apart from the perimeter area.

[0122] Example 17 may include, or optionally combine with the subject matter of one or any combination of Examples 11 to 16, to optionally include, an alignment groove that tapers between the first support surface and the second support surface.

[0123] Example 18 may include, or optionally combine with the subject matter of one or any combination of Examples 11 to 17, to optionally include a handle that may extend from the peripheral area of ​​the edge near the alignment slot.

[0124] Example 19 may include, or optionally combine with the subject matter of one or any combination of Examples 11 to 18, to optionally include a handle, which may include: a curved segment extending from a peripheral edge region; and a straight segment connected to the curved segment; wherein the curved segment positions the straight segment to align with an alignment groove.

[0125] Example 20 may include, or optionally combine with, the subject matter of one or any combination of Examples 11 to 19 to optionally include a femoral component, which may include: a first condyle; a second condyle connected to the first condyle; a first alignment port located in the first condyle and configured to align with a first stud; and a second alignment port located in the second condyle and configured to align with a second stud.

[0126] Example 21 may include or use a subject such as a tibial spacer system, which may include: a temporary component that may include: a body, an articular connection surface positioned on the body and configured to engage with the condylar surface of the femoral component, and an alignment tab extending from the body; and a dimensional adjustment extension extending from the body on the opposite side of the articular connection surface, the dimensional adjustment extension may include: a bone engagement surface, an edge peripheral region extending from the bone engagement surface, and a first alignment indicator located on the edge peripheral region of the dimensional adjustment extension.

[0127] Example 22 may include, or optionally combine with the subject matter of Example 21, to optionally include, a femoral component comprising: a first condyle; a second condyle connected to the first condyle; and a pin port extending into the femoral component, the pin port being configured to align with an alignment tab.

[0128] Example 23 may include, or optionally combine with the subject matter of one or any combination of Examples 21 or 22, to optionally include a pin configured to be inserted into a pin port.

[0129] Example 24 may include, or optionally combine with the subject matter of one or any combination of Examples 21 to 23, to optionally include an alignment tab that may include a notch configured to receive a pin when the femoral component is in an extended position relative to the articular connection surface.

[0130] Example 25 may include, or optionally combine with the subject matter of one or any combination of Examples 21 to 24, to optionally include, a body of a temporary component that can be integrated into an integral component and a size-adjusting extension.

[0131] Example 26 may include, or optionally combine with the subject of one or any combination of Examples 21 to 25, to optionally include a sizing extension that may include a plate that can be attached to the body of a temporary component.

[0132] Example 27 may include, or optionally combine with the subject matter of one or any combination of Examples 21 to 26, to optionally include a plurality of temporary components, wherein each of the plurality of temporary components includes a different thickness.

[0133] Example 28 may include, or optionally combine with the subject matter of one or any combination of Examples 21 to 27, to optionally include, a second alignment indicator located on the peripheral region of the edge of the sizing extension; wherein the first alignment indicator is located near the center of the rear portion of the peripheral region, and the second alignment indicator is spaced apart from the first alignment indicator.

[0134] Example 29 may include or use a subject such as a tibial spacer system, which may include: a temporary component that may include: an articular connection surface configured to engage a condylar surface of a femoral component, a first support surface disposed on the opposite side of the articular connection surface, and an edge peripheral region connecting the articular connection surface and the first support surface; a specimen support that may include: a bone engagement surface, a second support surface disposed on the opposite side of the bone engagement surface, and a second edge peripheral region connecting the bone engagement surface and the second support surface; and a pivotal connection connecting the first support surface and the second support surface, configured to allow the specimen support to rotate relative to the temporary component.

[0135] Example 30 may include, or optionally combine with the subject matter of Example 29, to optionally include a pivot connection that may include: a stud extending from a second support surface; and a slot extending into a first support surface; wherein the stud is positioned aligned with the slot when the second edge peripheral region is substantially aligned with the first edge peripheral region.

[0136] Example 31 may include, or optionally combine with the subject matter of one or any combination of Examples 29 or 30, to optionally include a stud located on a second support surface to be coaxial with the mechanical axis of the tibia; and a slot located on a first support surface to be coaxial with the mechanical axis of the tibia.

[0137] Example 32 may include, or optionally combine with the subject matter of one or any combination of Examples 29 to 31, to optionally include a temporary component, which may further include an alignment tab extending from the peripheral region of the first edge.

[0138] Example 33 may include, or optionally combine with the subject matter of one or any combination of Examples 29 to 32, to optionally include a femoral component, which may include: a first condyle; a second condyle connected to the first condyle; and a pin port extending into the femoral component, the pin port being configured to align with an alignment tab.

[0139] Example 34 may include, or optionally combine with the subject matter of one or any combination of Examples 29 to 33, to optionally include a pin configured to be inserted into a pin port.

[0140] Example 35 may include, or optionally combine with the subject matter of one or any combination of Examples 29 to 34, to optionally include an alignment tab that may include a notch configured to receive a pin when the femoral component is in an extended position relative to the articular connection surface.

[0141] Example 36 may include, or optionally combine with the subject matter of one or any combination of Examples 29 to 35, to optionally include, a first edge peripheral region of the first alignment indicator.

[0142] Example 37 may include, or optionally combine with the subject matter of one or any combination of Examples 29 to 36, to optionally include, a second alignment indicator located on a first edge peripheral region of the temporary component; wherein the first alignment indicator is located near the center of the rear portion of the first edge peripheral region, and the second alignment indicator is spaced apart from the first alignment indicator.

[0143] Example 38 may include, or optionally combine with the subject matter of one or any combination of Examples 29 to 37, to optionally include a plurality of temporary components, each of the plurality of temporary components including a different thickness.

[0144] Each of these non-restrictive examples may exist independently or may be combined with one or more other examples in various permutations or combinations.

[0145] The above detailed description includes reference to the accompanying drawings, which form part of the detailed description. The drawings illustrate specific embodiments in which the invention can be practiced. These embodiments are also referred to herein as “examples.” These examples may include elements other than those shown or described. Nevertheless, the inventors have also contemplated examples that provide only those elements shown or described. Furthermore, the inventors have contemplated examples using any combination or arrangement of those elements (or one or more aspects thereof) shown or described with respect to a particular example (or one or more aspects thereof) or with respect to other examples (or one or more aspects thereof) shown or described herein.

[0146] In the event of any inconsistency between the usage in this article and any references incorporated by way of citation, the usage in this article shall prevail.

[0147] In this document, the terms “a” or “an” are commonly used in patent literature to include one or more, independent of any other examples or uses of “at least one” or “one or more.” In this document, the term “or” is used to indicate non-exclusivity, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In this document, the terms “comprising” and “wherein” are used as common English equivalents to the corresponding terms “including” and “in…”. Furthermore, in the following claims, the terms “comprising” and “including” are open-ended, meaning that a system, apparatus, article, composition, formulation, or process including elements other than those listed after this term in the claim is still considered to be within the scope of that claim. Additionally, in the following claims, the terms “first,” “second,” and “third,” etc., are used merely as designations and are not intended to impose numerical requirements on their objects.

[0148] The above description is intended to be illustrative and not restrictive. For example, the above examples (or one or more aspects thereof) may be used in combination with each other. After reading the above description, those skilled in the art may use other embodiments. An abstract is provided to allow the reader to quickly determine the nature of the technical disclosure. The abstract is provided to be understood as not being intended to interpret or limit the scope or meaning of the claims. Moreover, in the above specific embodiments, various features may be combined together to simplify this disclosure. This should not be construed as meaning that any unclaimed disclosed feature is essential to any claim. Rather, the subject matter of the invention may lie in fewer than all features of a particular disclosed embodiment. Thus, the following claims are incorporated into the specific embodiments as examples or embodiments, wherein each claim is itself a separate embodiment, and it is contemplated that these embodiments may be combined with each other in various combinations or orders. The scope of the invention should be determined with reference to the appended claims and the full scope of the equivalents conferred by those claims.

Claims

1. A tibial spacer system, the tibial spacer system comprising: A femoral component, the femoral component including a pin port extending therein; A pin, the pin being configured to be inserted into the pin port; A temporary component comprising: a body; an articular connection surface positioned on the body and configured to engage the condylar surface of a femoral component; a support surface disposed on the opposite side of the articular connection surface; an edge peripheral region connecting the articular connection surface and the support surface; and an alignment tab extending outwardly from the edge peripheral region of the body; and a sizing extension connected from the support surface to the body, the sizing extension comprising: a bone engagement surface; an edge peripheral region extending from the bone engagement surface; and a first alignment indicator positioned on the edge peripheral region of the sizing extension, the first alignment indicator being located at the center of the front portion of the edge peripheral region of the sizing extension, wherein a pin port is configured to align with the alignment tab, and wherein the alignment tab includes a notch configured to receive the pin when the femoral component is in an extended position relative to the articular connection surface.

2. The tibial spacer system according to claim 1, characterized in that, The femoral component includes: a first condyle; and a second condyle connected to the first condyle.

3. The tibial spacer system according to claim 1 or 2, characterized in that, The main body and the dimensional adjustment extension of the temporary component are integrated into a single component.

4. The tibial spacer system according to claim 1 or 2, characterized in that, The sizing extension includes a plate that can be attached to the body of the temporary component.

5. The tibial spacer system according to claim 1 or 2, characterized in that, The tibial spacer system also includes a plurality of the temporary components, each of which has a different thickness.

6. The tibial spacer system according to claim 1 or 2, characterized in that, The tibial spacer system further includes a second alignment indicator located on the peripheral region of the edge of the sizing extension, wherein the second alignment indicator is spaced apart from the first alignment indicator.

7. A tibial spacer system, the tibial spacer system comprising: A femoral component, the femoral component including a pin port extending therein; A pin, the pin being configured to be inserted into the pin port; A temporary component comprising: an articular connection surface configured to engage a condylar surface of a femoral component; a first support surface disposed on the opposite side of the articular connection surface; a first peripheral edge region connecting the articular connection surface and the first support surface, the first peripheral edge region including a first alignment indicator located at the center of the front portion of the first peripheral edge region; and an alignment tab extending outwardly from the first peripheral edge region; a specimen support comprising: a bone engagement surface; a second support surface disposed on the opposite side of the bone engagement surface; and a second peripheral edge region connecting the bone engagement surface and the second support surface; and a pivot connection connecting the first support surface and the second support surface, the pivot connection being configured to allow the specimen support to rotate relative to the temporary component along a pivot axis, wherein a pin port is configured to align with the alignment tab, and wherein the alignment tab includes a notch configured to receive the pin when the femoral component is in an extended position relative to the articular connection surface.

8. The tibial spacer system according to claim 7, characterized in that, The pivot connection includes: a stud extending from the second support surface; and a slot extending into the first support surface; wherein the stud is positioned to align with the slot when the second edge peripheral region is aligned with the first edge peripheral region.

9. The tibial spacer system according to claim 8, characterized in that: The stud is positioned on the second support surface so as to be coaxial with the mechanical axis of the tibia; and the slot is positioned on the first support surface so as to be coaxial with the mechanical axis of the tibia.

10. The tibial spacer system according to any one of claims 7-9, characterized in that, The femoral component includes: a first condyle; and a second condyle connected to the first condyle.

11. The tibial spacer system according to any one of claims 7-9, characterized in that, The tibial spacer system further includes a second alignment indicator located on the peripheral region of the first edge of the temporary member, wherein the second alignment indicator is spaced apart from the first alignment indicator.

12. The tibial spacer system according to any one of claims 7-9, characterized in that, The tibial spacer system also includes a plurality of the temporary components, each of which has a different thickness.

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