Patellar implants for knee arthroplasty
By designing accurate tibial implants and adopting a position verification system, the problem of inaccurate installation of knee arthroplasty implants is solved, achieving higher installation accuracy and better patient recovery results.
Patent Information
- Application Number
- CN202210230651.4
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2021-03-10
- Filing Date
- 2022-03-10
- Publication Date
- 2025-05-13
- Estimated Expiration
- 2042-03-10
AI Technical Summary
There are inaccurate problems in the installation and positioning of existing knee arthroplasty implants, which affects the success rate of the surgery and the recovery effect of the patient.
A tibial implant including a tibial plate, a tibial keel and an anchoring protrusion was designed, and a position verification system was used to verify the correct position of the implant through positioning indicators and trackers.
Through the use of precise tibial implant design and position verification system, the installation accuracy of the implant is improved, the surgical time and complications are reduced, and the patient's recovery effect is improved.
Smart Images

Figure CN115068174B_ABST
Abstract
Description
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS
[0002] This patent application is a continuation-in-part of U.S. patent application No. 17 / 011,049 filed on September 3, 2020, the entire contents of which are hereby incorporated by reference in their entirety for all purposes. Technical Field
[0003] The present disclosure relates generally to knee arthroplasty, and in particular to knee arthroplasty implants and methods of installing knee arthroplasty implants. Background Art
[0004] Knee arthroplasty, commonly referred to as knee replacement, is a surgical procedure used to reconstruct and resurface a knee joint that has been damaged, such as by arthritis. A total knee arthroplasty device replaces the tibiofemoral joint and the patellofemoral joint. The tibiofemoral joint is where the tibia and femur articulate. The patellofemoral joint is where the patella and femur articulate. To replace the tibiofemoral joint, a knee arthroplasty includes a femoral trial (or implant) fixed to the distal end of the femur, a tibial tray (or implant) fixed to the proximal end of the tibia, and an insert disposed therebetween. The femoral implant and the tibial implant respectively cover the ends of the femur and tibia that form the knee joint, thereby reconstructing the knee joint. To replace the patellofemoral joint, a knee arthroplasty includes a patellar prosthesis (or implant) to replace the back of the patella and form a replacement articulating surface that interfaces with the femoral trial. Summary of the invention
[0005] In one aspect, a tibial implant for knee arthroplasty comprises a tibial plate, the size and shape of which are adapted to be placed on the proximal end of the patient's tibia. The tibial plate comprises a relative proximal surface and a distal surface. The distal surface is configured to engage the end of the tibia. The tibial keel extends distally from the distal surface of the tibial plate and is configured to be inserted into the proximal end of the tibia. At least one anchoring projection extends distally from the distal surface of the tibial plate and is configured to be inserted into the proximal end of the tibia.
[0006] On the other hand, a method for verifying implantation of a tibial implant relative to the proximal end of a patient's tibia includes: positioning the tibial implant relative to the proximal end of the tibia; positioning a position indicator of a position verification system relative to the tibial implant; determining the position of the tibial implant by tracking the position of the position indicator using a tracker of the position verification system; determining the position of the tibia; and verifying that the tibial implant is correctly positioned relative to the proximal end of the tibia by comparing the position of the tibial implant relative to the position of the tibia.
[0007] On the other hand, a patella implant for knee arthroplasty includes a cover including an articulating surface. The cover has a plurality of first connecting members. A base is configured to be attached to the back of a patient's patella. The base includes a cover support mounted to the cover. The cover support includes a plurality of first connecting recesses. Each first connecting member of the cover is disposed in a corresponding one of the first connecting recesses of the cover support to mount the cover to the base.
[0008] On the other hand, a base of a patella implant for knee arthroplasty includes a cover support configured to be attached to a cover of the patella implant. The cover support includes a plurality of first connection recesses. Each first connection recess is configured to receive a corresponding first connection member of the cover to attach the cover to the cover support. At least one anchoring protrusion extends from the cover support and is configured to be inserted into the back side of the patella.
[0009] In another aspect, a method of forming a patella implant includes forming a base having a plurality of first connection recesses and molding a material onto the base to form a cap having an articulating surface. The molding includes substantially filling the plurality of first connection recesses with the material.
[0010] Other objects and features of the disclosure will be in part apparent and in part pointed out hereinafter. BRIEF DESCRIPTION OF THE DRAWINGS
[0011] Figure 1 is a front perspective view of a tibial implant according to one embodiment of the present disclosure;
[0012] Figure 2 yes Figure 1 A bottom perspective view of a tibial implant;
[0013] Figure 3 yes Figure 1 A bottom plan view of a tibial implant;
[0014] Figure 4 is a bottom perspective view of a tibial implant according to another embodiment of the present disclosure;
[0015] Figure 5 is a bottom plan view of a tibial implant according to another embodiment of the present disclosure;
[0016] Figure 6 yes Figure 5 An enlarged partial bottom perspective view of a tibial implant;
[0017] Figure 7 is a bottom perspective view of a tibial implant according to another embodiment of the present disclosure;
[0018] Figure 8is a bottom perspective view of a tibial implant according to another embodiment of the present disclosure;
[0019] Fig. 9 is a bottom perspective view of a tibial implant according to another embodiment of the present disclosure;
[0020] Fig.10 is a bottom perspective view of a tibial implant according to another embodiment of the present disclosure;
[0021] Fig.11 is a bottom perspective view of a tibial implant according to another embodiment of the present disclosure;
[0022] Fig.12 yes Fig.11 an enlarged partial side elevation view of an anchoring projection of a tibial implant;
[0023] Fig.13 is a bottom perspective view of a tibial implant according to another embodiment of the present disclosure;
[0024] Fig.14 yes Fig.13 an enlarged partial side elevation view of an anchoring projection of a tibial implant;
[0025] Fig.15 is a bottom perspective view of a tibial implant according to another embodiment of the present disclosure;
[0026] Fig.15A yes Fig.15 An enlarged partial bottom perspective view of a tibial implant;
[0027] Fig.16 is a front bottom perspective view of a tibial implant according to another embodiment of the present disclosure;
[0028] Fig.17 yes Fig.16 A perspective view of the posterior bottom of the tibial implant;
[0029] Fig.18 Yes Fig.16 A perspective view of an installation tool assembly with a tibial implant installed on a proximal end of a patient's tibia;
[0030] Fig.19 is a front perspective view of an impact guide of the installation tool assembly;
[0031] Fig. 20 is a rear perspective view of the clamping guide;
[0032] Fig.21 is a bottom perspective view of a tibial implant according to another embodiment of the present disclosure;
[0033] Fig. 22 yes Fig.21 A bottom plan view of a tibial implant;
[0034] Fig.23 is a side elevation view of a patella implant according to one embodiment of the present disclosure;
[0035] Fig.24 is a cross-section of the patellar implant;
[0036] Fig.25 is a bottom plan view of the patellar implant;
[0037] Fig.26 is a schematic diagram of a position verification system in which a position indicator engages a positioning guide of a tibial implant to verify the position of the tibial implant relative to a proximal end of a patient's tibia;
[0038] Fig. 27 yes Fig.26 A perspective view of a position indicator engaging a positioning guide of a femoral implant to verify the position of the femoral implant relative to a distal end of a patient's femur;
[0039] Fig.28 yes Fig.26 a perspective view of a position indicator engaging a tibial mounting tool attached to a tibial implant to verify the position of the tibial implant relative to the proximal end of the tibia;
[0040] Fig.29 yes Fig.26 a perspective view of a position indicator engaging a femoral installation tool attached to a femoral implant to verify the position of the femoral implant relative to a distal end of the femur;
[0041] Fig.30 yes Fig.26 a perspective view of a position indicator engaging a tibial implant to verify the position of the tibial implant relative to the proximal end of the tibia;
[0042] Fig.31 yes Fig.26 a perspective view of a position indicator engaging a femoral implant to verify the position of the femoral implant relative to a distal end of the femur;
[0043] Fig.32 is a perspective view of a position indicator of a position verification system secured to a tibial mounting tool attached to a tibial implant for verifying the position of the tibial implant relative to a proximal end of the tibia;
[0044] Fig.33 yes Fig.32a perspective view of a position indicator secured to a femoral installation tool attached to a femoral implant for verifying the position of the femoral implant relative to a distal end of the femur;
[0045] Fig.34 yes Fig.26 a perspective view of a position indicator secured to a tibial covering attached to a tibial implant for verifying the position of the tibial implant relative to a proximal end of the tibia;
[0046] Fig.35 yes Fig.32 a perspective view of a position indicator secured to a femoral covering attached to a femoral implant for verifying the position of the femoral implant relative to a distal end of the femur; and
[0047] Fig.36 is a side view of a patella implant according to another embodiment of the present disclosure;
[0048] Fig.37 is its bottom plan;
[0049] Fig.38 yes Fig.36 a bottom plan view of a base of a patellar implant;
[0050] Fig.39 yes Fig.36 an enlarged partial side perspective view of a base of a patellar implant;
[0051] Fig.40 yes Fig.36 an enlarged partial top perspective view of a base of a patellar implant;
[0052] Fig.41 yes Fig.36 an enlarged partial cross-section of a base of a patellar implant;
[0053] Fig.42 yes Fig.36 an enlarged partial cross-section of a patellar implant showing a cover of the patellar implant connected to a base;
[0054] Fig.43 yes Fig.42 A magnified view of
[0055] Fig.44 yes Fig.36 an enlarged partial top perspective view of a patellar implant of , with portions of the cover hidden from view to more clearly illustrate the interconnection of the connecting members of the cover with the base;
[0056] Fig.45 yes Fig.36 Cross-section of the patellar implant;
[0057] Fig.46 yes Fig.45 A magnified view of
[0058] Fig.47 is a top plan view of a base of a patella implant according to another embodiment of the present disclosure;
[0059] Fig.48 yes Fig.47 A side elevation view of the base of;
[0060] Fig.49 yes Fig.47 A cross section of the base;
[0061] Fig.50 is a bottom plan view of a patella implant according to another embodiment of the present disclosure, the patella implant comprising Fig.47 The base of
[0062] Fig.51 is a side elevation view of a patella implant according to another embodiment of the present disclosure;
[0063] Fig.52 yes Fig.51 A bottom perspective view of a patellar implant;
[0064] Fig.53 is a side elevation view of a base of a patella implant according to another embodiment of the present disclosure;
[0065] Fig.54 is a bottom perspective view of a patella implant according to another embodiment of the present disclosure;
[0066] Fig.55 yes Fig.54 An enlarged partial perspective view of an anchoring protrusion of a patellar implant;
[0067] Fig.56 yes Fig.54 an enlarged partial cross-section of an anchoring protrusion of a patella implant; and
[0068] Fig.57 yes Fig.54 An enlarged partial bottom view of the anchoring protrusion of the patella implant.
[0069] Corresponding reference numerals indicate corresponding parts throughout the drawings. DETAILED DESCRIPTION
[0070] Various different systems and methods for performing and executing knee arthroplasty are disclosed herein. The different systems for knee arthroplasty disclosed herein include implants (e.g., tibial implants, femoral implants, patellar implants), installation or arthroplasty tools for installing implants; and position verification systems for determining and verifying the position of implants relative to bones. The different methods for knee arthroplasty disclosed herein include methods for installing implants and methods for verifying the position of installed implants relative to bones.
[0071] refer to Figures 1 to 3 One embodiment of a tibial tray or implant for knee arthroplasty according to one embodiment of the present disclosure is generally indicated by reference numeral 10. The tibial implant 10 includes a tibial plate 12 that is sized and shaped to be placed on the proximal end PE (100) of the patient's tibia T. Fig.18 ) on. The tibial plate 12 can generally have any size and shape to match the specific size and shape of the proximal end PE of the tibia T to which the tibial implant is attached. The tibial plate 12 includes a relative proximal surface 14 and a distal surface 16. The distal surface 16 of the tibial plate 12 is configured to engage the proximal end PE of the tibia T. The tibial plate 12 has a peripheral edge limit 18. In the illustrated embodiment, the tibial plate 12 includes a peripheral wall 20, which extends proximally from the proximal surface 14. The peripheral wall 20 includes a peripheral edge limit 18. The peripheral wall 20 defines an insert receiving space 22, the size and shape of which are set to receive an insert (not shown). The peripheral wall 20 may include one or more recesses or notches 24, which are used to receive a part of an insert to keep the insert in the insert receiving space 22. The proximal surface 14 defines the distal end or bottom end of the insert receiving space 22.
[0072] The tibial implant 10 may include at least one (eg, a plurality of) positioning guides 26 configured to be positioned by the position verification system 1400 ( Fig.26) engages (as discussed in more detail below) to verify the position of the tibial implant relative to the proximal end PE of the tibia T after the tibial implant is implanted (e.g., placed) on the proximal end of the tibia. The positioning guide 26 is used to position or align the position verification system 1400 relative to the tibial implant 10, as discussed in more detail below. The size and shape of the positioning guide 26 are set to cooperate with the elements or components (e.g., position indicator 1402) of the position verification system 1400. Therefore, the positioning guide 26 is a touch point for the position verification system 1400. One or more positioning guides 26 are set at a position accessible to the tibial implant 10 after the implant is attached to the tibia T. In the illustrated embodiment, the positioning guide 26 is set on the tibial plate 12. Specifically, the positioning guide 26 is set on the peripheral edge limit 18 of the tibial plate 12 and is advantageously set on the front portion of the peripheral edge limit so that the positioning guide is easy to access after the tibial implant 10 is implanted. Other locations for the positioning guide 26 are also within the scope of the present disclosure. For example, the positioning guide 26 can be disposed on the proximal surface 14. The positioning guide 26 can be a positive element (such as a protrusion) or a negative element (such as a recess). In the illustrated embodiment, the positioning guide 26 is a recess or a depression. Thus, the positioning guide 26 of the illustrated embodiment is configured to receive or be engaged by the position verification system 1400. The recess 26 can generally have any shape, such as, but not limited to, Figure 1 The tibial implant 10 of the present invention is provided with the tibial implant 10 of the present invention.The tibial implant 10 of the present invention is provided with the tibial implant 10 of the present invention.The tibial implant 10 of the present invention is provided with the tibial implant 10 of the present invention.The tibial implant 10 of the present invention is provided with the tibial implant 10 of the present invention.The tibial implant 10 of the present invention is provided with the tibial implant 10 of the present invention.The tibial implant 10 of the present invention is provided with the tibial implant 10 of the present invention.The tibial implant 10 of the present invention is provided with the tibial implant 10 of the present invention.The tibial implant 10 of the present invention is provided with the tibial implant 10 of the present invention.The tibial implant 10 of the present invention is provided with the tibial implant 10 of the present invention.The tibial implant 10 of the present invention is provided with the tibial implant 10 of the present invention.The tibial implant 10 of the present invention is provided with the tibial implant 10 of the present invention.The tibial implant 10 of the present invention is provided with the tibial implant 10 of the present invention. For example, the distance between the positioning guides 26 may represent (e.g., encode) the size of the tibial implant 10 (e.g., the spacing between the positioning guides 26 varies with the size of the implant) and the position verification system 1400 may determine the size of the implant tibial implant by referencing an implant database to confirm the correct size of the implanted tibial implant.
[0073] Tibial implant 10 includes a tibial stem or keel 28. Tibial keel 28 is configured to be inserted into the proximal end PE of tibia T. Tibial keel 28 is attached to tibial plate 12. Tibial keel 28 generally extends distally from the distal surface 16 of tibial plate 12. In the illustrated embodiment, tibial keel 28 is generally straight. Tibial keel 28 may be solid or hollow (e.g., with a solid or hollow core). Tibial keel 28 may include coronal fins 30 (e.g., two coronal fins). The coronal fins 30 extend outwardly from the center of tibial keel 28 in a direction roughly parallel to the patient's coronal plane (e.g., vertical left and right extension plane). In the illustrated embodiment, the coronal fins 30 are at a slight angle (such as about 15 degrees or less) relative to the coronal plane to form a slight V shape. Tibial keel 28 may also include sagittal fins 32 (e.g., two sagittal fins). The sagittal fin 32 extends outward from the center of the tibial keel 28 in a direction generally parallel to the patient's sagittal plane (e.g., a vertical anteroposterior extension plane). The coronal fin 30 and the sagittal fin 32 taper inwardly as the fins extend distally. The width of the sagittal fin 32 may also taper inwardly (e.g., in a direction generally parallel to the coronal plane) as the fins extend distally. The fins 30, 32 have rounded edges. The nose or tip of the tibial keel 28 tapers (e.g., is curved) in the coronal plane. In other embodiments, the nose of the tibial keel 28 may also taper in the sagittal plane. Other configurations of the tibial keel are also within the scope of the present disclosure, some of which are disclosed herein.
[0074] refer to Figure 2 and Figure 3 , the tibial implant 10 may include at least one anchoring projection 34. In the illustrated embodiment, the tibial implant 10 includes four anchoring projections 34, but more or fewer anchoring projections are also within the scope of the present disclosure. The anchoring projections 34 are spaced apart from each other above the distal surface 16 of the tibial plate 12. In the illustrated embodiment, the four anchoring projections 34 are arranged in a generally X arrangement around the tibial keel 28, with the tibial keel at the center of the X. Other arrangements of the anchoring projections 34 are also within the scope of the present disclosure.
[0075] Each anchoring projection 34 is configured to be inserted into the proximal end PE of the tibia T. Each anchoring projection 34 is substantially the same, and therefore one anchoring projection will be further described in detail, and it should be understood that the other anchoring projections have substantially the same configuration (e.g., disposed at different locations on the tibial plate 12). The anchoring projection 34 is attached to the tibial plate 12. The anchoring projection 34 extends generally distally from the distal surface 16 of the tibial plate 12. The anchoring projection 34 has a distal end or distal tip 36. In this embodiment, the distal tip 36 includes a recess. The recess may generally have any shape, such as, but not limited to, a conical shape (e.g., an inverted cone), but other shapes are also within the scope of the present disclosure, such as a conical shape with a flat bottom, a partial spherical shape, a hemispherical shape, a cylindrical shape, a rectangular shape, a square shape, a pyramidal shape. When the tibial implant 10 is implanted in the tibia T, the recess maximizes the pressure fit of the anchoring protrusion 34 with the bone to increase the compression between the anchoring protrusion and the bone, thereby stimulating the healing of the bone. In addition, the recess is conducive to forming a sharp leading distal edge at the distal tip 36 to facilitate the insertion of the anchoring protrusion 34 into the proximal end PE of the tibia T. In the illustrated embodiment, the anchoring protrusion 34 has a generally circular shape, a conical shape (e.g., a bullet shape), but other shapes (such as a circular shape, a blade shape, or a hollow shape) are also within the scope of the present disclosure. The anchoring protrusion 34 includes a plurality of ribs 38 extending proximally from the distal tip 36. The ribs 38 extend proximally to the distal surface 16 of the tibial plate 12. In the illustrated embodiment, the anchoring protrusion 34 includes six ribs 38, but more (e.g., 20) or less (e.g., 4) ribs are also within the scope of the present disclosure. The ribs 38 are disposed circumferentially around the anchoring protrusion 34. The ribs 38 have beveled edges, but in other embodiments, the ribs may have rounded edges, chamfered edges, sharp edges, rounded edges, etc. In this embodiment, the ribs 38 are curved (e.g., slightly curved) around the longitudinal axis of the anchoring protrusion 34. The longitudinal axis extends proximally and distally through the distal tip 36 of the anchoring protrusion 34. In other words, the ribs 38 are spirally or partially spirally curved around the longitudinal axis. In the illustrated embodiment, each rib 38 includes a proximal portion extending substantially straight distally from the distal surface 16 and a distal portion extending distally from the proximal portion around the longitudinal axis in a curved manner to the distal tip 36. As the ribs extend distally, the ribs 38 taper inwardly (e.g., toward the longitudinal axis) toward the distal tip 36. The taper may be straight or curved. Other configurations of the ribs 38 are also within the scope of the present disclosure. Adjacent ribs 38 define therebetween grooves 40. The grooves 40 extend from the distal surface 16 to the distal tip 36 and the shape of the grooves generally corresponds to the shape of the ribs 38. Thus, the grooves 40 are also curved about the longitudinal axis.The design of the ribs 38 (and more broadly the anchoring protrusions 34) minimizes bone displacement, minimizes fracture risk, and increases the surface area of the anchoring protrusions for bone ingrowth. Other configurations of the anchoring protrusions are also within the scope of the present disclosure, some of which are disclosed herein. The anchoring protrusions 34 can be solid or hollow (e.g., having a solid or hollow core).
[0076] Tibial implant 10 may include one or more porous regions.Porous regions are arranged on the tibial implant at the position engaged with tibia T (bone in a broad sense).After the tibial implant is placed on the bone to form a firm connection between the implant and the bone, the porous region enables bone to grow inwardly into the tibial implant 10.This allows the tibial implant 10 to be inserted into the tibia T without the conventional cement used in knee arthroplasty, thereby reducing the operative time, the complications associated with the cement and the pressure of the surgeon.The porosity of the porous region can be within the closed interval of about 40% to 90%, or more preferably within the closed interval of about 50% to 80%.The porous region can have a thickness of about 1mm to 1.5mm.In the embodiment shown, the distal surface 16 of the tibial plate 12 is porous (e.g., porous region).Other parts of the tibial implant 10 may include porous regions. For example, in one embodiment, at least a portion of the tibial keel 28 and / or the anchoring projection 34 is porous so that bone can grow inwardly into the tibial keel and / or the anchoring projection 34 after the tibial implant 10 is inserted into the proximal end PE of the tibia T or implanted on the proximal end PE of the tibia T. Any surface of the tibial keel 28 and the anchoring projection 34 can be porous. Preferably, the porous area extends distally along the tibial keel 28 and the anchoring projection 34 from the distal surface 16 of the tibial plate 12. Preferably, the porous area of the tibial keel 28 and / or the anchoring projection 34 extends distally up to about 10mm and includes a distance of about 10mm from the distal surface 16. This allows bone to grow into the tibial keel 28 and / or the anchoring projection 34 while still allowing the implant to be easily removed when the tibial implant 10 needs to be adjusted or replaced in the future. The porous region of the tibial keel 28 and / or the anchoring projection 34 may extend (e.g., cover) more of the tibial keel and / or the anchoring projection 34 (including all of it) to enable a stronger connection to be formed between the tibial keel and / or the anchoring projection 34, but if removal is required, it will be more difficult to remove and replace such a tibial implant from the bone. In one embodiment, the porous region includes a plurality of porous regions that are coupled together to form a lattice ( Figure 2 and Fig.25 ) of hexagonal struts, but any suitable porous structure is also within the scope of the present disclosure.
[0077] The tibial implant 10 can be manufactured using conventional manufacturing processes and methods and / or additive manufacturing processes and methods (e.g., three-dimensional (3D) printing). In one manufacturing method, additive manufacturing is used to construct the entire tibial implant 10. In this method, the tibial implant 10 is constructed by an additive manufacturing machine (e.g., a 3D printer), which generally constructs the implant on a base plate and post-processes the implant before removing the implant from the base plate. In another manufacturing method, hybrid manufacturing is used to construct the tibial implant 10, which combines conventional manufacturing methods with additive manufacturing. In this hybrid method, the tibial plate 12 of the implant 10 can be first formed by conventional manufacturing methods such as cold forming (e.g., stamping, cutting, deformation) of a metal blank or by forging a tibial plate. Then, the tibial plate 12 is placed in an additive manufacturing machine, which constructs additional elements (e.g., keel 28, anchoring protrusion 34, porous area, etc.) on the tibial plate. Preferably, the porous region of the tibial implant 10 is constructed using additive manufacturing. The additive manufacturing machine constructs (e.g., is configured to construct) a porous region (e.g., a lattice of hexagonal stays) on a component (e.g., tibial plate 12) of the tibial implant. Compared with conventional methods, additive manufacturing is more likely to be able to construct a more complex porous structure. For example, conventional manufacturing methods cannot construct a porous region composed of a lattice of hexagonal stays. Various additive manufacturing processes can be used to form porous regions, such as 3D printing, direct metal laser sintering (DMLS), titanium deposition spraying, etc. Other methods of constructing porous regions are also within the scope of the present disclosure. For example, a subtractive manufacturing process (such as laser etching or acid etching) can be used to construct porous regions.
[0078] Other configurations of tibial implants are also within the scope of the present disclosure.For example, a tibial implant can have one or more of the tibial keels and / or anchoring projections described below.
[0079] refer to Figure 4 , the anchoring projection of the tibial implant 110 according to another embodiment of the present disclosure is generally indicated by the reference numeral 134. In this embodiment, the ribs 138 of the anchoring projection 134 are generally straight and parallel to the longitudinal axis and extend toward the longitudinal axis (e.g., not bent around the longitudinal axis). In this embodiment, the distal tip 136 of the anchoring projection 134 includes an end point (e.g., a tapered end point).
[0080] refer to Figure 5 and Figure 6 The anchoring protrusion of the tibial implant 210 according to another embodiment of the present disclosure is generally indicated by the reference numeral 234. In this embodiment, the anchoring protrusion 234 includes four ribs 238 ( Figure 5). The ribs 238 are also generally straight and extend parallel to and toward the longitudinal axis. The distal tip 236 also includes an endpoint similar to the anchoring protrusion 134. In this embodiment, the ribs 238 are spaced apart from the distal surface 16 of the tibial paddle 12. The ribs 238 extend proximally from the distal tip 236 to a position intermediate the distal tip and the distal surface 16. Each rib 238 includes a proximal surface facing the distal surface 16 and spaced apart from the distal surface. The proximal surface of the ribs 238, the distal surface 16 of the tibial paddle 12, and the base of the ribs (not shown) together define a space for bone (e.g., tibia T) to grow into and surround the rib. In other embodiments, the ribs 238 may extend all the way to the distal surface 16, such as Fig.16 , Fig.17 , Fig.21 and Fig. 22 The ribs of the anchoring protrusion 234A.
[0081] refer to Figure 7 , the anchoring projection of the tibial implant 310 according to another embodiment of the present disclosure is generally indicated by the reference numeral 334. In this embodiment, the anchoring projection 334 is cylindrical (e.g., having a cylindrical shape). The anchoring projection 334 includes a cylindrical outer surface 335 and a leading or distal surface 336. The distal surface is generally planar (e.g., the distal end 336 is generally blunt) and has a circular shape. The edge or corner between the outer surface 335 and the distal surface 336 is circular, but in other embodiments, the edge or corner may have a beveled edge, a chamfered edge, a sharp edge, a rounded edge, etc.
[0082] refer to Figure 8 , the anchoring protrusion of the tibial implant 410 according to another embodiment of the present disclosure is generally indicated by the reference numeral 434. In this embodiment, the anchoring protrusion 434 is generally cylindrical with a cylindrical outer surface 435. The distal end 436 includes a recess, which in the embodiment shown is an inverted cone, but other configurations as described herein are also within the scope of the present disclosure. In this embodiment, the width or diameter of the base of the inverted cone recess at the distal end 436 is approximately equal to the width or diameter of the cylindrical outer surface 435, but the base of the recess with a smaller width is also within the scope of the present disclosure. The anchoring protrusion 434 includes a sharp leading or distal edge at the distal end 436 between the recess at the distal end 436 and the cylindrical outer surface 436.
[0083] refer to Fig. 9, the anchoring projection of the tibial implant 510 according to another embodiment of the present disclosure is generally indicated by the reference numeral 534. In this embodiment, the anchoring projection 534 has a generally polygonal (e.g., hexagonal) shape, which tapers inwardly as the anchoring projection extends distally. The surface 541 of the polygonal shape is concave. Therefore, the edge between the surfaces generally defines the ridge 538 with a sharp edge of the anchoring projection 534. In this embodiment, the distal end 536 has a generally flat distal surface.
[0084] refer to Fig.10 , the anchoring projection of the tibial implant 610 according to another embodiment of the present disclosure is generally indicated by the reference numeral 634. In this embodiment, the anchoring projection 634 has a generally polygonal (e.g., hexagonal) shape, which tapers inwardly as the anchoring projection extends distally. The surface 641 of the polygonal shape is concave. Therefore, the edge between the surfaces generally defines the ridge 638 of the anchoring projection 634. In this embodiment, the ridge 638 is circular. The distal end 636 has a recess, such as an inverted cone.
[0085] refer to Fig.11 and Fig.12 , the anchoring projection of the tibial implant 710 according to another embodiment of the present disclosure is generally indicated by the reference numeral 734. In this embodiment, the anchoring projection 734 has a generally polygonal (e.g., hexagonal) shape, which tapers inwardly as the anchoring projection extends distally. The surface 741 of the polygonal shape is concave. Therefore, the edge between the surface 741 generally defines the ridge 738 with sharp edges of the anchoring projection 734. As the ridge 738 extends distally, the ridge is bent roughly around the longitudinal axis LA of the anchoring projection. Therefore, as the anchoring projection extends distally, the polygonal cross-sectional shape rotates roughly around the longitudinal axis LA. The distal end 736 has a recess (such as an inverted hexagonal cone), but other shapes such as those described herein are also within the scope of the present disclosure. The anchoring projection 734 includes a sharp leading or distal edge 737 between the recess at the distal end and the surface 741 at the distal end 736. The distal edge 737 has a polygonal (eg, hexagonal) shape made of a plurality of straight line segments. The straight line segments of the distal edge 737 are substantially coplanar.
[0086] refer to Fig.13 and Fig.14, the anchoring projection of the tibial implant 810 according to another embodiment of the present disclosure is generally indicated by the reference numeral 834. In this embodiment, the anchoring projection 834 has a generally polygonal (e.g., hexagonal) shape, which tapers inwardly as the anchoring projection extends distally. The surface 841 of the polygonal shape is concave. Therefore, the edge between the surface 841 generally defines the ridge 838 with sharp edges of the anchoring projection 834. As the ridge 838 extends distally, the ridge is bent roughly around the longitudinal axis LA of the anchoring projection. Therefore, as the anchoring projection extends distally, the polygonal cross-sectional shape rotates roughly around the longitudinal axis LA. The distal end 836 has a recess (such as an inverted hexagonal cone), but other shapes such as those described herein are also within the scope of the present disclosure. The anchoring projection 834 includes a sharp leading or distal edge 837 between the recess at the distal end and the surface 841 at the distal end 836. The distal edge 837 has a generally polygonal (e.g., hexagonal) shape made of a plurality of segments. In this embodiment, the segments of the distal edge 837 are arcuate or curved (e.g., curved generally around an axis (e.g., a horizontal axis) extending generally perpendicular to the longitudinal axis LA). Thus, the distal edge 837 has a generally sawtooth configuration, wherein the teeth or points are disposed at the intersection of two curved segments and the ridge 838 (e.g., defined by the intersection).
[0087] refer to Fig.15 and Fig.15A , an anchoring protrusion of a tibial implant 910 according to another embodiment of the present disclosure is generally indicated by reference numeral 934. In this embodiment, the anchoring protrusion 934 includes a cylindrical wall 939 extending distally from the distal surface 16 to a distal end 936. The cylindrical wall 939 includes a generally cylindrical outer surface 935 and a generally cylindrical inner surface 943. The cylindrical inner surface 943 defines a cavity or recess 945 of the anchoring protrusion, which is functionally similar to other recesses of the anchoring protrusions described herein. The cavity 945 extends from the distal surface 16 to the distal end 936. The distal end 936 includes a generally flat distal surface. The inner circumferential edge and / or the outer circumferential edge of the distal surface can be a beveled edge, a rounded edge, a chamfered edge, a sharp edge, a rounded edge, etc. In the illustrated embodiment, the inner edge of the distal surface of the distal end 936 is a beveled edge. The outer surface 943 and the inner surface 934 each include one or more (eg, a plurality) circumferential ridges 938 defined by circumferential, generally concave grooves extending into the cylindrical wall 939. The ridges 938 are spaced longitudinally along the cylindrical wall 939.
[0088] refer to Fig.16 and Fig.17, the tibial keel for tibial implant 1010 according to another embodiment of the present disclosure is generally indicated by reference numeral 128. In this embodiment, tibial keel 128 is arched or curved. As tibial keel extends distally from the distal surface of tibial plate, tibial keel 128 bends around the transverse axis of the patient (e.g., the transverse or left-right axis of the distal surface 16 of tibial plate 12 is roughly parallel). In other words, tibial keel 128 bends toward the front of tibial implant 1010 (e.g., in the forward direction). Therefore, when tibial implant 1010 is implanted on tibia T, tibial keel 128 bends toward the tibial tubercle of the patient. The tibial tubercle is a cortical protrusion, commonly used as a marker in orthopedic surgery. Contrary to other keel designs, aligning the nose of tibial keel 128 with the tibial tubercle ensures that there are other cortical fulcrums and reduces the chance of lifting off by being arranged closer to the cortical bone. In addition, the curved tibial keel 128 has a larger surface area than the straight keel design. The larger anterior surface or anterior surface and rear surface or rear surface of the tibial keel 128 provide greater resistance for the tibial implant 10 to lift off from the tibia T. In addition, due to the curved design, a part of the rear surface of the tibial keel 128 faces the distal side, thereby increasing the total amount of the surface area facing the distal side, which increases the ability of the tibial implant 1010 to resist sinking. Except that the tibial keel 128 is curved, the crown fin 130 and the sagittal fin 132 of the tibial keel include puncture edges. The edge of the fin 130,132 can be a tapered edge, a sharp edge and / or a toothed edge. Conventional insertion techniques need to be drilled into and / or pulled into the tibia T by the keel feature before inserting the implant. The puncture edge of the tibial keel 128 is conducive to the insertion of the tibial implant 1010, without any advance bone preparation or requiring minimum advance bone preparation. In addition, in this embodiment, the tibial keel 128 also includes an anchoring projection or spike 131. The anchoring projection 131 is configured to be inserted into the proximal end PE of the tibia T to further fix the tibial implant 1010 to the tibia. In the embodiment shown, the anchoring projection 131 is disposed on the rear side of the tibial keel 128, adjacent to the edge of the coronal fin 130.
[0089] refer to Figures 18 to 20, a mounting tool assembly for mounting a curved keel tibial implant (such as implant 1010) on the proximal end PE of a patient's tibia T is generally indicated by reference numeral 1200. The mounting tool assembly 1200 includes a tibial trial mold handle 1202 and a clamping guide 1212. The handle 1202 includes a footprint template 1204, which is used to determine the size of the tibial implant 1010 to be implanted on the tibia T. The footprint template 1204 may include one or more holes or spaces 1206 to allow the tibial keel and / or anchoring protrusion to be inserted into the proximal end PE of the tibia T, while the footprint template covers the tibia. The footprint template 1204 is releasably connected to one end of a shaft 1208. The shaft 1208 has a generally circular cross-sectional shape. As explained in more detail below, shaft 1208 includes a locating recess or depression 1210 for locating a clamp guide 1212 on handle 1202 .
[0090] The clamping guide 1212 is configured to insert the tibial implant 1010 in a curved manner (e.g., in a curved or arcuate path CP) into the proximal end PE of the tibia T. The clamping guide 1212 includes a mounting portion 1214 and a driving portion 1216. The mounting portion 1214 is configured to be connected (e.g., releasably connected) to the handle 1202. The mounting portion 1214 defines a handle opening 1218, the size and shape of which are set to receive the shaft 1208 of the handle. The handle opening 1218 has an opposite open end to allow the mounting portion 1214 to slide above the end of the shaft 1208 and along the shaft of the handle 1202. The cross-sectional shape of the handle opening 1218 matches or corresponds to the cross-sectional shape of the shaft 1208 of the handle 1202. Therefore, in the embodiment shown, the handle opening 1218 has a circular cross-sectional shape. The mounting portion 1214 includes a detent or catch 1220 configured to position and secure the mounting portion on the handle 1202. The detent 1220 is sized and shaped to be inserted into one of the recesses 1210 along the handle to position and lock the clamp guide 1212 in place on the handle 1202. In the locked position ( Fig. 20 ), the pawl 1220 extends generally into the handle opening 1220. When the clamping guide 1212 is mounted on the handle 1202, the pawl 1220 extends into the recess 1210 when the pawl is in the locked position. The pawl 1220 can be reliably biased toward the locked position, such as by a spring or a living hinge. The pawl is moved to a released position (not shown) such that the pawl 1220 is spaced apart from the recess 1210 (e.g., the handle opening 1218), thereby allowing the clamping guide 1212 to move or slide along the handle 1202.
[0091] The driving portion 1216 of the clamping guide 1212 is configured to keep the tibial implant 1010 and drive the tibial implant into the proximal end PE of the tibia T. The driving portion 1216 is pivotally connected to the mounting portion 1214. In the illustrated embodiment, the driving portion 1216 is connected to the mounting portion 1214 by a hinge 1222 (e.g., an axis extending through the alignment openings in the mounting portion and the driving portion). Therefore, the driving portion 1216 rotates approximately around the axis of rotation AR to drive the tibial implant 1010 into the tibia T. The driving portion 1216 includes a coupling head 1224, which is configured to be releasably connected to the tibial implant 1010. Specifically, the coupling head 1224 extends into the insert receiving space 22 and the recess 24 and engages the inner surface of the peripheral wall 20 to be connected to the tibial implant 1010. The coupling head 1224 is configured to form a snap fit or compression fit with the tibial implant 1010 to releasably connect to the tibial implant. The coupling head 1224 includes an insert 1226, 1228 (e.g., a front insert and a rear insert). The insert 1226, 1228 is configured to be inserted into the insert receiving space 22 and / or the recess 24. The insert 1226, 1228 is generally in line with a portion of the peripheral wall 20 of the tibial implant 1010. The insert 1226, 1228 is elastically biased away from each other. The insert 1226, 1228 is moved away from each other and engages the peripheral wall 20 of the tibial implant 1010 to fix the tibial implant to the clamping guide 1212. In order to attach the tibial implant 1010 or release the tibial implant from the coupling head 1224, the installation inserts 1226, 1228 are pushed toward each other to allow the inserts to move into or out of the insert receiving space 22. In the illustrated embodiment, the elastically deflectable arm 1230 couples the installation inserts 1226, 1228 together. The arm 1230 also defines a portion of the hinge 1222. The arm 1230 shown generally has a U-shaped shape. The coupling head 1224 also includes a contact surface 1232, which is configured to be engaged or struck by a hammer (not shown) so that the driving portion 1216 rotates around the axis of rotation AR and drives the tibial implant 1010 into the proximal end PE of the tibia T. The driving portion 1216 is configured so that when the tibial implant 1010 is attached to the coupling head 1224, the curved tibial keel 128 is approximately colinear with the axis of rotation AR around its curved axis of curvature. This allows the drive portion 1216 to move the tibial implant 1010 along a curved path that generally corresponds to and matches the curve of the tibial keel 128 .
[0092] In a method of operation using the installation tool assembly 1200, the surgeon uses the handle 1202 to select the appropriate size of the tibial implant 1010. The surgeon uses the footprint template 1204 (a procedure generally known in the art) to determine the size of the tibial implant 1010 to be implanted on the proximal end PE of the tibia T. The handle 1202 is also fixed to the appropriate position relative to the tibia T using conventional means known in the art. Once the size of the tibial implant 1010 is determined, the surgeon selects the tibial implant of the correct size and attaches it to the coupling head 1224 of the clamping guide 1216. The tibial implant 1010 is attached to the coupling head 1124 by moving the installation inserts 1226, 1228 toward each other so that they can be inserted into the insert receiving space 22. Once in the insert receiving space 22, the installation inserts 1226, 1228 are moved away from each other and engage the peripheral wall 20 to fix the implant to the clamping guide 1216. Then, the surgeon inserts the shaft 1208 of the handle 1202 through the handle opening 1218 of the mounting portion 1214 and slides the clamping guide 1216 along the handle. The surgeon aligns the pawl 1220 with the desired recess 1210 to set and fix the clamping guide 1212 in the desired position along the handle 1202. Afterwards, the surgeon uses a hammer to impact the contact surface 1232 and drives the tibial implant 1010 into the tibia T. The hammer rotates the driving portion 1216 and the tibial implant 1010 around the rotation axis AR, thereby moving the tibial implant 1010 along a curved path. In one embodiment, the surgeon can completely hammer the tibial implant 1010 into the proximal end PE of the tibia T before removing the installation tool assembly 1200. In another embodiment, the surgeon can partially hammer the tibial implant 1010 into the proximal end PE of the tibia T, and then remove the installation tool assembly 1200. After removing the installation tool assembly 1200, the surgeon moves the tibial implant 1010 to the remainder in the tibia T. For example, the surgeon can drive the tibial implant to a middle position, such as about halfway into the tibia T. In this embodiment, as the implant is further driven into the tibia T, the curved tibial keel 128 continues to guide the tibial implant 1010 along a curved path. In order to separate the tibial implant 1010 from the tibial implant 1010, the surgeon installs inserts 1226, 1228 toward each other, and then moves out of the insert receiving space 22. As mentioned above, the tibial keel 128 of the tibial implant 1010 has a sharp edge, which allows implanting the tibial implant 1010 without the need to implant some pre-bone preparations required for conventional tibial implants. Specifically, the step (for example, pre-drilling) of preparing tibia T for the tibial keel is eliminated.Additionally, implantation of the curved keel tibial implant 1010 as described herein reduces dislocation, distraction, and spacing required to install the tibial implant as compared to conventional straight keel implant techniques.
[0093] refer to Fig.21 and Fig. 22 , the tibial keel for tibial implant 1110 according to another embodiment of the present disclosure is generally indicated by reference numeral 228. In this embodiment, the tibial keel 228 has a coronal fin 230 and a sagittal fin 232. In this embodiment, the edge of the fin and the nose of the tibial keel 228 are generally blunt (e.g., generally flat). In addition, the sagittal fin 232 of the tibial keel 228 includes a concave side 233. Other configurations of the tibial keel are also within the scope of the present disclosure. For example, in one embodiment, the tibial implant includes a tibial keel (not shown) that is angled with the vertical direction such as tilted forward (rather than bent forward). The tilt angle of the tibial keel makes it easier to implant the tibial implant on the proximal end PE of the tibia T. The tilted tibial keel allows the tibial implant to start from a more forward or more forward position, and then as the implant is driven into the proximal end PE of the tibia T, it moves backward or backward due to the tilted keel. Being able to start implantation of the tibial implant at a more anterior position compared to a straight keel may provide more clearance between the implant and other parts of the patient's body (such as the femur) and / or other surgical tools, making it easier to insert the implant into the tibia T.
[0094] It should be understood that the elements, features and methods of the tibial implants 10, 110, 210, 310, 410, 510, 610, 710, 810, 910, 1010, 1110 described herein and the elements, features and methods associated therewith can be applied to other bone implants, including but not limited to femoral implants and patellar implants. For example, the porous area of the tibial implant can be incorporated into other bone implants (such as patellar implants). Examples of such patellar implants are described in Figure 23 to Figure 251310. The patella implant 1310 is sized and shaped to be implanted on the back of the patella. The patella implant 1310 includes a proximal or articulating surface 1314 and an opposing distal surface 1316. The distal surface 1316 is configured to engage the back of the patella. The articulating surface 1314 has a partial dome shape. As discussed above, the patella implant 1310 includes a porous region. Specifically, the distal surface 1316 is porous (e.g., a porous region). In the illustrated embodiment, a portion of the distal surface 1316 is porous, but in other embodiments, the entire distal surface 1316 may be porous. The porous portion of the distal surface 1316 is approximately located at the center of the distal surface and is spaced apart from the peripheral edge of the distal surface. The porous region has a generally circular shape disposed within the larger circular shape of the distal surface 1316. As shown in the illustrated embodiment, the porous region includes generally hexagonal struts coupled together to form a lattice, but any suitable porous structure is also within the scope of the present disclosure. As mentioned above, the porosity of the distal surface 1316 allows the patella implant 1310 to be inserted into or implanted on the patella without the cement conventionally used in knee arthroplasty, thereby reducing surgical time, cement-related complications and surgeon stress.
[0095] The patella implant 1310 includes a cover 1350 and a base or anchor 1352 coupled together. The cover 1350 defines (e.g., includes) a portion of the articulation surface 1314 and a distal surface 1316. In the illustrated embodiment, the portion of the distal surface 1316 defined by the cover 1350 is not porous. The cover 1350 may be made of a polymer material or any other suitable material. The base 1352 defines a portion of the distal surface 1316. In the illustrated embodiment, the portion of the distal surface 1316 defined by the bottom 1352 is porous. The base 1352 also includes at least one (e.g., multiple) anchoring protrusion 1334 similar to the anchoring protrusion discussed above. In the illustrated embodiment, the patella implant 1310 includes three anchoring protrusions 1334, but more or fewer anchoring protrusions are also within the scope of the present disclosure. Each anchoring protrusion 1334 extends generally distally from the distal surface 1316. In this embodiment, each anchoring projection 1334 is cylindrical (e.g., has a cylindrical shape) with an oblate conical distal tip 1336. The anchoring projection 1334 is also solid ( Fig.24 ), but in other embodiments, the anchoring protrusion may be hollow. The base 1352 may be made of metal or any other suitable material.
[0096] The cover 1350 and the base 1352 are configured to be coupled together to form the patella implant 1310. In the illustrated embodiment, the cover 1350 and the base 1352 are configured to form a snap-fit connection. The base 1352 includes a support ring 1354 having opposing inner and outer circumferential edge boundaries or surfaces. Fig.24 As shown in , the inner edge limit and the outer edge limit of the support ring 1354 taper away from each other as the edge limit extends generally upward. Therefore, the proximal end of the support ring 1354 is wider than the distal end of the support ring (e.g., a generally dovetail cross-sectional shape). The cover 1350 includes a generally circumferential channel 1356 or recess that is sized and shaped to receive the support ring 1354. The support ring 1354 and the channel 1356 have corresponding sizes and shapes. The cover 1350 includes opposing inner and outer circumferential surfaces that define the sides of the channel 1356. The inner and outer surfaces of the cover 1350 correspond to the taper of the inner and outer edge limits of the support ring 1354. As shown in FIG. Fig.24 As shown in, the inner surface and outer surface of cover 1350 also taper away from each other as the surface generally extends upward. Therefore, the mouth of passage 1356 is narrower than its base (e.g., approximately dovetail cross-sectional shape). In order to assemble patella implant 1310, the support ring 1354 of base 1352 is inserted into the passage 1356 of cover 1350. Cover 1350 is elastically deformable and deformable to expand the mouth of passage 1356, to allow support ring 1354 to pass through the passage before returning or rebounding to its initial or static state, thereby fixing cover and base 1352 together. Cover 1350 engages support ring 1354 to fix base 1352 to cover. The tapered inner surface and outer surface of cover 1350 and support ring 1354 engage each other respectively, to fix cover and bottom 1352 together. The support ring 1352 also provides rigidity to the patella implant 1310 and provides a mounting platform for the porous structure (eg, hexagonal struts).
[0097] The base 1352 can be constructed using the manufacturing techniques and processes discussed herein. For example, as mentioned above, the base 1352 can be constructed using hybrid manufacturing. In the hybrid manufacturing process, the support ring 1354 and the anchoring protrusion 1334 can first be created by conventional manufacturing methods such as cold forming (e.g., stamping, cutting, deformation) of a metal blank or by forging. The partially formed base 1352 is then placed in an additive manufacturing machine that builds a porous area on the base. The cover 1350 is then attached to the base 1352 to complete the construction of the patella implant 1310. The polymer cover 1350 can be formed by conventional methods (such as compression molding).
[0098] refer to Figure 26 to Figure 35, various different systems and methods for verifying the implantation of an implant relative to a patient's bone are disclosed. The following description describes different systems and methods for verifying the position or placement of a knee arthroplasty implant relative to a bone. For example, these systems and methods can be used to verify the position of any implant in a tibial implant 10 or the implant disclosed herein relative to the proximal end PE of a patient's tibia T. However, it should be understood that these systems and methods for verifying the position of an implant can also be used in other surgical applications except knee arthroplasty.
[0099] Total knee arthroplasty relies on the correct placement of femoral implants and tibial implants. In conventional knee arthroplasty surgery, the final placement of the implant depends on the surgical skills in both placing the implant on the bone and performing sawing on the bone where the implant is located. There are a variety of different systems for forming saw cuts in the bone. For example, the sawing of the implant can be driven by a manual, non-computer-assisted instrument, or by a navigation instrument that provides computer-assisted feedback on the sawing positioning, or by a surgical robot that provides robot-assisted guidance in sawing positioning. Further details about surgical robots and robot-assisted guidance for sawing positioning can be found in U.S. Patent Application No. 16 / 737,054 filed on January 8, 2020, the entire contents of which are incorporated herein by reference. Although the implant roughly follows the sawing, in conventional knee arthroplasty, the final position of the implant still depends on surgical experience, skill, feel, and eyes. The following systems and methods provide verification and confirmation of the position of the implant on the patient's bone.
[0100] It should be understood that the systems (e.g., surgical robots, tracking systems, etc.) and methods for performing knee arthroplasty disclosed in U.S. patent application Ser. No. 16 / 737,054 can be used to perform, guide, assist in, and / or be used in conjunction with knee arthroplasty using the systems (e.g., implants, position verification systems, etc.) and methods (e.g., implant implantation, position verification, etc.) described herein.
[0101] refer to Fig.26, a position verification system according to an embodiment of the present disclosure is generally indicated by reference numeral 1400. The position verification system 1400 is configured to verify or determine the position of the tibial implant 10 relative to the proximal end PE of the tibia T. The position verification system 1400 can be used during and / or after the tibial implant 10 is implanted on the proximal end PE of the tibia T. The position verification system 1400 includes a position indicator 1402 and a tracker 1410 (e.g., a tracking system). The position indicator 1402 is configured to indicate the position of the tibial implant 10. The tracker 1410 is configured to track or locate the position of the position indicator 1402 in real time (in 3D space) in order to determine the position of the tibial implant 10. The position indicator 1402 is configured to be positioned relative to the tibial implant 10 to indicate the position of the tibial implant. The position indicator 1402 includes a plurality of (e.g., four) tracking marks or indicators 1404 tracked by the tracker 1410. Indicator 1404 is a visual marker or optical marker recognized by tracker 1410. In the illustrated embodiment, indicator 1404 is a sphere or ball, but any suitable optical marker is within the scope of the present disclosure. Position indicator 1402 has a fixed geometry and tracker 1410 knows the geometry of the position indicator. Therefore, by tracking the position of indicator 1404 on position indicator 1402, tracker 1410 can determine or infer the location that the position indicator is contacting or coupled to. Fig.26 In the embodiment shown in, position indicator 1402 comprises stylus. Stylus 1402 has a tip. In one embodiment, the tip of stylus 1402 is a ball or sphere. As will be explained in more detail below, the surgeon may engage the tip of stylus 1402 with different components (e.g., tibial implant 10, arthroplasty tool, etc.) to determine the position of tibial implant. Tracker 1410 knows the position of the tip of stylus 1402 relative to indicator 1404. Tracker 1410 can use the known geometry of indicator 1404 and stylus to determine the position of the tip of stylus 1402, and thereby determine the position of the thing that the tip of stylus is contacting or engaging. Other configurations of position indicator 1402 are also within the scope of the present disclosure, and some of these configurations are disclosed herein. For example, position indicator 1402 may be a dynamic reference array as described in U.S. Patent Application No. 16 / 737,054.
[0102] Tracker 1410 tracks or locates position indicator 1402 to determine the position of the position indicator in 3D space. Tracker 1410 may be a camera-based tracker (e.g., camera tracking system), such as the camera-based tracker described in U.S. Patent Application No. 16 / 737,054. Tracker 1410 includes one or more cameras 1412, which are wired or wirelessly connected to tracking computer 1414 (e.g., communicate with the tracking computer). Camera 1412 is configured to capture an image (e.g., picture, video, etc.) of position indicator 1402, and tracking computer 1414 determines the position of position indicator and tibial implant 10 based on the indicator 1404 in the image from the camera. Tracking computer 1414 may include a display (e.g., video display) to output information to the surgeon, such as the position of the proximal end PE of tibial implant 10 relative to tibia T. Tracker 1410 can also determine the position of bone (for example, tibia T) in 3D space, as described in U.S. Patent Application No. 16 / 737,054, but other modes of determining the position of bone are also within the scope of the present disclosure. Generally speaking, tracker 1410 compares the position of tibia T with the position of tibial implant 10 to determine the position of implant relative to tibia. Then tracker 1410 outputs or displays this information to the surgeon. It should be understood that position verification system 1400 can be a part for a larger surgical system (for example, a larger robotic surgical system).
[0103] The position verification system 1400 can be used in a variety of different ways to determine the position of the tibial implant 10 relative to the proximal end PE of the tibia T. Fig.26In the illustrated method of operation, the position verification system 1400 is configured to cooperate or align with one or more positioning guides 26 of the tibial implant 10 to determine the position of the tibial implant. In this embodiment, the position indicator 1402 (e.g., the tip of the stylus) cooperates or aligns with one or more positioning guides 26 of the tibial implant 10. For example, the tip of the stylus 1402 is inserted into the recess 26 of the tibial implant 10. Then, the tracker 1410 determines the position of one or more positioning guides 26 (e.g., recess) to determine the position of the tibial implant 10 relative to the proximal end PE of the tibia T. For example, in an exemplary method, the surgeon positions the tibial implant 10 relative to the proximal end PE of the tibia such as by placing the tibial implant on the proximal end of the tibia. Afterwards, the surgeon positions the position indicator 1402 relative to the tibial implant 10. The tracker 1410 tracks the position indicator 1402 to determine the position of the tibial implant 10 (e.g., the position of the tibial implant in 3D space). In this embodiment, the surgeon uses the stylus 1402 to align or engage (e.g., touch) various positioning guides 26 (e.g., the position indicator directly engages the implant) with the tip. When the position indicator 1402 is positioned relative to the tibial implant 10, the tracker 1410 tracks the position of the position indicator. Specifically, the tracker 1410 tracks the stylus 1402 to determine the position of the positioning guide 26 and infer or determine the position of the tibial implant. In one embodiment, the surgeon informs the tracker 1410 via the user interface of the tracker when the stylus 1402 is aligned with the positioning guide 26, so the tracker knows which positions of the position indicator correspond to the position of the tibial implant 10 (e.g., positioning guide). As with the position indicator 1402, in this embodiment, the tracker 1410 knows the geometry of the tibial implant 10 and can determine the position of the tibial implant based on the known geometry of the tibial implant and the position of the positioning guide 26. In one embodiment, the tracker 1410 accesses the geometry of the implant based on the position of the positioning guide 26. As mentioned above, the position of positioning guide 26 can be used for encoding information peculiar to this pattern (for example, type, size, etc.) of implant.After determining the position of positioning guide 26, tracker 1410 can access implant database and use positioning guide information (for example, the distance between positioning guide) to locate specific implant and associated implant information (such as name, type, size, geometry, etc.) in database.In other embodiments, surgeon can manually provide this information to tracker via user interface, or input the information that allows tracker to access the correct implant entry in implant database.
[0104] Continuing the method, at a certain point, tracker 1410 determines or is notified of the position of tibia T (for example, the position of tibia in 3D space). This can be carried out before, during or after determining the position of tibial implant 10. Then, the position of tibial implant 10 in 3D space is compared with respect to the position of tibia T in 3D space to verify whether tibial implant is correctly positioned on the proximal end PE of tibia. Tracker 1410 provides feedback about the position of tibial implant 10 relative to tibia T to the surgeon. Tracker 1410 can compare the position of tibia T and tibial implant 10, or information can be displayed to allow the surgeon to compare the position of tibial implant and tibial implant. Tracker 1410 or the surgeon can compare the position of tibial implant 10 relative to tibia T (for example, the position on tibia) with baseline or ideal position to determine whether tibial implant is correctly positioned. The ideal position is such as previously determined by the surgeon and is the theoretically perfect position of the tibial implant 10 on the tibia T (e.g., relative to the proximal end PE of the tibia). If the position of the tibial implant 10 relative to the tibia T is aligned with the ideal position (or within an appropriate error margin), the tibial implant is correctly positioned and the surgeon can proceed with the remainder of the surgical procedure. If the position of the tibial implant 10 relative to the tibia T is not aligned with the ideal position, the surgeon adjusts the position of the implant as needed before continuing with the surgical procedure. After repositioning the tibial implant 10, the surgeon can repeat the above steps to determine whether the new or adjusted position of the tibial implant is correct. The same process can be used to determine the position of other implants relative to the bone. For example, if Fig. 27 As shown, the same process can be used to verify the position of the femoral implant 11 by aligning the position indicator 1402 of the position verification system 1400 with one or more positioning guides 26 of the femoral implant.
[0105] refer to Fig.28In another method of operation, the position verification system 1400 is configured to cooperate or align with one or more positioning guides 26 on an arthroplasty tool 1420 (e.g., a tibial mounting tool, a femoral mounting tool) to determine the position of the tibial implant 10. The arthroplasty tool 1420 is configured to be releasably attached to the tibial implant 10. When the arthroplasty tool 1420 and the tibial implant 10 are coupled together, the arthroplasty tool is rigidly and immovably fixed to the tibial implant. The arthroplasty tool 1420 can be any suitable tool, such as an implant (e.g., a tibial implant, a femoral implant) holder. As described above, the arthroplasty tool 1420 includes one or more positioning guides 26. In this embodiment, the position indicator 1402 (e.g., the tip of the stylus) cooperates or aligns with one or more positioning guides 26 of the arthroplasty tool 1420 (e.g., the position indicator indirectly engages the implant via the tool). Then the tracker 1410 determines the position of one or more positioning guides 26 (e.g., recesses) to determine the position of the arthroplasty tool 1420 and then the position of the tibial implant 10. For example, in an exemplary method, the surgeon positions the tibial implant 10 relative to the proximal end PE of the tibia, such as by placing the tibial implant on the proximal end of the tibia. In one embodiment, the surgeon can use the arthroplasty tool 1420 to place the tibial implant 10 and attach the tool to the implant. In another embodiment, the surgeon attaches the arthroplasty tool 1420 to the tibial implant 10 after the tibial implant is implanted on the tibia T. Afterwards, the surgeon positions the position indicator 1402 relative to the tibial implant 10. The tracker 1410 tracks the position indicator 1402 to determine the position of the tibial implant 10. In this embodiment, the surgeon uses the stylus 1402 to align or engage (e.g., touch) the various positioning guides 26 of the arthroplasty tool 1420 with the tip. When the position indicator is aligned with the positioning guide 26 of the arthroplasty tool 1420, the tracker 1410 tracks the position of the position indicator 1402. The tracker 1410 tracks the stylus 1402 to determine the position of the positioning guide 26 and infer or determine the position of the arthroplasty tool 1420 and the position of the tibial implant 10. As with the position indicator 1402, in this embodiment, the tracker 1410 knows the geometry of the tibial implant 10, the geometry of the arthroplasty tool 1420, and the relative orientation and position of the tibial implant and the arthroplasty tool when the arthroplasty tool is attached to the tibial implant. The tracker 1410 uses this information to determine the position of the tibial implant based on the position of the positioning guide 26. As discussed above, the positioning guide 26 can be used to access relevant information about the arthroplasty tool (e.g., the geometry, orientation and position of the tibial implant attached to the tool).
[0106] After the tracker 1410 determines the position of the tibial implant 10, the process is substantially the same as described above. The tracker 1410 determines or is notified of the position of the tibia T. The position of the tibial implant 10 is then compared relative to the position of the tibia T to verify that the tibial implant is properly positioned on the proximal end PE of the tibia. If the position of the tibial implant 10 relative to the tibia T is correct, the surgeon can proceed with the remainder of the surgical procedure. If the position of the tibial implant 10 is incorrect relative to the position of the tibia T, the surgeon adjusts the position of the implant as needed before continuing with the surgical procedure. The same process can be used to determine the position of other implants relative to the bone. For example, Fig.29 As shown, the same process can be used to verify the position of the femoral implant 11 by aligning the position indicator 1402 of the position verification system 1400 with one or more positioning guides 26 of the arthroplasty tool 1420 connected to the femoral implant.
[0107] refer to Fig.30In another method of operation, position verification system 1400 is configured to engage tibial implant 10 at multiple different positions on tibial implant to determine the position of tibial implant. In this embodiment, the surgeon rubs or moves position indicator 1402 (for example, the tip of stylus) on all or part of tibial implant 10. When position indicator engages tibial implant 10 and moves on this tibial implant, tracker 1410 tracks position indicator 1402 to generate information (for example, turbidity point or turbidity point data) corresponding to the size, shape and position of tibial implant. For example, in an exemplary method, the surgeon positions tibial implant 10 relative to the proximal end PE of tibia, such as by placing tibial implant on the proximal end of tibia to locate. Afterwards, the surgeon positions position indicator 1402 relative to tibial implant 10. Tracker 1410 tracks position indicator 1402 to determine the position of tibial implant 10. In this embodiment, the surgeon rubs or moves the tip of the stylus 1402 on the tibial implant 10 or its target area. For example, the surgeon can move the stylus back and forth on the tibial implant 10. In this embodiment, the tip of the stylus 1402 is configured to not damage (e.g., scratch) the tibial implant 10 when the tip slides on the implant. When the position indicator rubs the tibial implant, the tracker 1410 tracks the position of the position indicator 1402. The tracker 1410 tracks the stylus 1402 to determine the position of the tibial implant 10. When the tracker 1410 tracks the stylus, the turbidity data corresponding to the size, shape (e.g., profile) and position of the tibial implant 10 are generated. Like the position indicator 1402, in this embodiment, the tracker 1410 knows the geometry of the tibial implant 10 and uses this information to determine the position of the tibial implant based on the turbidity data. Similar to the positioning guide 26 discussed above, in one embodiment, cloud point data can be used to access relevant information (e.g., geometry) about tibial implant 10 from the implant database. Tracker 1410 can use surface matching algorithm to align geometry information or data from the implant database of tibial implant 10 with cloud point data to determine the position of tibial implant 10.
[0108] After the tracker 1410 determines the position of the tibial implant 10, the process is substantially the same as that described in the above-described embodiments. The tracker 1410 determines or is notified of the position of the tibia T. The position of the tibial implant 10 is then compared relative to the position of the tibia T to verify whether the tibial implant is correctly positioned on the proximal end PE of the tibia. If the position of the tibial implant 10 relative to the tibia T is correct, the surgeon can proceed with the remainder of the surgical procedure. If the position of the tibial implant 10 is incorrect relative to the position of the tibia T, the surgeon adjusts the position of the implant as needed before continuing with the surgical procedure. The same process can be used to determine the position of other implants relative to the bone. For example, as Fig.30 As shown, the same process can be used to verify the position of the femoral implant by gently rubbing the position indicator 1402 of the position verification system 1400 on the femoral implant 11.
[0109] refer to Fig.32 , another embodiment of the position indicator of the positioning system 1400 is generally indicated by the reference numeral 1403. In this embodiment, the position indicator 1403 is an array mounted (e.g., connected) to an arthroplasty device (such as a tool, an accessory, or an implant). The array 1403 includes a frame supporting an indicator 1404. The position indicator 1403 can be releasably connected to the arthroplasty device or fixed to the arthroplasty device. When the position indicator 1403 is mounted on the arthroplasty device, the position indicator is rigidly and immovably fixed to the arthroplasty device. As discussed above, the position indicator 1403 includes an indicator 1404. In this embodiment, the position indicator 1403 is rigidly connected to an arthroplasty tool 1420 (such as an implant holder). As discussed above, the arthroplasty tool 1420 is configured to be releasably attached to the tibial implant 10.
[0110] In an exemplary method of operation, a position verification system 1400 is configured to track a position indicator 1403 connected to an arthroplasty tool 1420 to determine the position of a tibial implant 10. In this embodiment, the position verification system 1400 can provide feedback to the surgeon about the placement of the tibial implant 10 during implantation and after implantation is complete. Due to the ability to determine the position of the tibial implant 10 relative to tibia T during implantation, the quality and quantity of the available bone stock can be improved. This can also eliminate the extra step of checking the position of the implant after implantation. In an exemplary method, a position verification system 1400 is used during implantation to guide the tibial implant 10 to the position on the tibia T. The surgeon attaches an arthroplasty tool 1420 with a position indicator 1403 to the tibial implant 10 (e.g., the surgeon positions the position indicator relative to the tibial implant). The surgeon then positions the tibial implant 10 relative to the proximal end PE of the tibia. The surgeon uses arthroplasty tool 1420 to move tibial implant 10 to the appropriate position on the proximal end PE of tibia T (e.g., to move the tibial implant toward the tibia). Tracker 1410 tracks position indicator 1403 to determine the position of tibial implant 10. When the position indicator moves toward tibia T along with arthroplasty tool 1420 and tibial implant 10, tracker 1410 tracks the position of position indicator 1403. Tracker 1410 determines or infers the position of tibial implant 10 based on the position of position indicator 1403. In this embodiment, tracker 1410 knows the geometry of tibial implant 10, the geometry of arthroplasty tool 1420 (including the position of position indicator 1403 relative to arthroplasty tool) and the relative orientation and position of tibial implant and arthroplasty tool when arthroplasty tool is attached to tibial implant. Tracker 1410 uses this information to determine the position of tibial implant based on the position of position indicator 1403.
[0111] In one embodiment, the relevant information that determines the position of tibial implant 10 (for example, the geometry of tibial implant, the geometry of arthroplasty tool 1420 (including the position of position indicator 1403 relative to arthroplasty tool) and the relative orientation and position of tibial implant and arthroplasty tool when arthroplasty tool is attached to tibial implant) can be stored in implant database.In this embodiment, the surgeon can inform tracker 1410 via user interface which tibial implant 10 and arthroplasty tool 1420 are being used, and access appropriate information from implant database.In another embodiment, the relevant information that will be used to determine the position of tibial implant 10 is imparted to tracker 1410.In this embodiment, tibial implant 10 is attached to arthroplasty tool 1420 and then is displayed to tracker 1410, and this tracker then determines (for example, collects) necessary information.For example, the surgeon can use the variable area of tibial implant to calibrate the position of tibial implant 10 relative to arthroplasty tool 1420. In this embodiment, the tracker 1410 may prompt the surgeon to touch specific points on the tibial implant 10 and / or the arthroplasty tool 1420 using the stylus 1402 to calibrate the tracker 1410 using a surface matching algorithm.
[0112] After tracker 1410 determines the position of tibial implant 10, the process is roughly the same as the process described in the above-mentioned embodiment. Tracker 1410 determines or is notified of the position of tibia T. Then the position of tibial implant 10 is compared relative to the position of tibia T, so as to verify whether tibial implant is moving towards the correct position on the proximal end PE of tibia. When using position verification system 1400 during placing or implanting tibial implant 10 on tibia T, tracker 1410 or surgeon can compare the position of tibial implant relative to ideal position, to verify that tibial implant is moving towards ideal position (for example, in line with ideal position) (because tibial implant is implanted on the proximal end PE of tibia T). If tibial implant 10 is moving towards ideal position, surgeon can continue to move tibial implant 10 towards tibia T (for example, insert) and make it enter in tibia, without any adjustment. If the tibial implant does not move toward the ideal position (e.g., is off track), the surgeon can make necessary adjustments and corrections while moving the tibial implant 10 toward and into the tibia T. In this way, the position verification system 1400 guides the tibial implant 10 toward the ideal position.
[0113] In another exemplary method, after tibial implant is implanted on tibia T, arthroplasty tool 1420 is connected or reconnected to tibial implant 10, to verify the position of tibial implant relative to tibia. In this embodiment, the surgeon will attach arthroplasty tool 1420 with position indicator 1403 to the tibial implant 10 implanted in tibia T (for example, the surgeon positions the position indicator relative to the tibial implant). Tracker 1410 tracks position indicator 1403 to determine the position of tibial implant 10. Tracker 1410 tracks or locates the position of the position indicator 1403 installed on the arthroplasty tool 1420 that is connected to tibial implant 10. Tracker 1410 locates position indicator 1403 to determine or infer the position of tibial implant 10. As mentioned above, tracker 1410 knows the geometry of tibia implant 10, the geometry of arthroplasty tool 1420 (comprising position indicator 1403 with respect to the position of arthroplasty tool) and the relative orientation and the position of tibia implant and arthroplasty tool when arthroplasty tool was attached to tibia implant. Tracker 1410 uses this information to determine the position of tibia implant 10 based on the position of position indicator 1403.
[0114] After the tracker 1410 determines the position of the tibial implant 10, the process is roughly the same as the process described in the above-mentioned embodiment. The tracker 1410 determines or is notified of the position of tibia T. The position of the tibial implant 10 is then compared relative to the position of tibia T, so as to verify whether the tibial implant is correctly positioned on the proximal end PE of the tibia. When the position verification system 1400 is used to verify the position of the tibial implant 10 relative to tibia T after the implant is implanted, the tracker 1410 or the surgeon can compare the position of the tibial implant relative to the ideal position, to verify or confirm the correct position of the tibial implant on the tibia. If the position of the tibial implant 10 relative to the position of tibia T is aligned with the ideal position, the tibial implant is correctly positioned and the surgeon can proceed to the remainder of the surgical operation. If the position of the tibial implant 10 is not aligned with the ideal position relative to the position of tibia T, the surgeon adjusts the position of the implant as needed before proceeding with the surgical operation. After verifying the position of the tibial implant 10, the arthroplasty tool 1420 can be removed or disengaged from the implant. These same procedures can be used to determine the position of other implants relative to the bone. Fig.33 As shown, the same process can be used to verify the position of the femoral implant 11 by tracking the position indicator 1403 of the position verification system 1400 mounted on the arthroplasty tool 1420 connected to the femoral implant.
[0115] refer to Fig.34In one embodiment, the position verification system 1400 includes an implant cover 1422. The implant cover 1422 is configured to be releasably coupled to the implant. The size and shape of the implant cover 1422 are set to be coupled to the type of implant to which the cover corresponds. For example, the implant cover 1422 ( Fig.34 ) can be similar to an insert and is sized and shaped to be fixed in the insert receiving space 22 of the implant. In another embodiment, the implant cover 1422 is used for the femoral implant 11 ( Fig.35 ) and its size and shape are set to be fastened on the implant. When the implant cover 1422 is connected to the implant, the implant cover is rigidly and immovably fixed to the implant. Preferably, the implant cover 1422 is roughly assembled on the articulated surface of the implant. Generally speaking, the tracker 1410 uses the position of the implant cover 1422 to determine the position of the implant. In this embodiment, the position indicator 1402, 1403 is rigidly connected to the implant cover 1422. Fig.34 One type of position indicator 1402, namely a stylus, is shown coupled to an implant cover 1422 of a tibial implant 10, and Fig.35 Another type of position indicator 1403, i.e. array, that is connected to the implant covering for femoral implant 11 is shown. Other types of position indicators may also be connected to the implant covering. In one embodiment, the implant covering 1422 may be connected to the implant to verify the position of the implant after the implant is placed on the bone. In another embodiment, the implant covering 1422 may be connected to the implant to guide implantation when the implant is being implanted on the bone.
[0116] Still reference Fig.34In an exemplary method of operation, a position verification system 1400 is configured to track a position indicator 1402 coupled to an implant covering 1422 to determine the position of a tibial implant 10. In this embodiment, the position verification system 1400 can provide feedback to the surgeon about the placement of the tibial implant 10 during implantation and after implantation is complete. In an exemplary method, a position verification system 1400 is used during implantation to guide the tibial implant 10 to a position on the tibia T. The surgeon attaches an implant covering 1422 with a position indicator 1402 to the tibial implant 10 (e.g., the surgeon positions the position indicator relative to the tibial implant). The surgeon also attaches an arthroplasty tool 1420 to the tibial implant 10. In one embodiment, the implant covering 1422 is disposed between the tibial implant 10 and the arthroplasty tool 1420 and moves with the arthroplasty tool. The surgeon then positions the tibial implant 10 relative to the proximal end PE of the tibia. The surgeon uses arthroplasty tool 1420 to move the tibial implant 10 to the appropriate position on the proximal end PE of tibia T (e.g., to move the tibial implant toward the tibia). Tracker 1410 tracks position indicator 1402 to determine the position of tibial implant 10. When the position indicator moves toward tibia T along with implant covering 1422, arthroplasty tool 1420 and tibial implant 10, tracker 1410 tracks the position of position indicator 1402. Tracker 1410 tracks position indicator 1402 to determine the position of implant covering 1422 and determine or extrapolate the position of tibial implant 10 connected thereto. In this embodiment, tracker 1410 knows the geometry of tibial implant 10, the geometry of implant covering 1422 (including the position of position indicator 1402 relative to implant covering) and the relative orientation and position of tibial implant and implant covering when implant covering is attached to tibial implant. The tracker 1410 uses this information to determine the position of the tibial implant 10 based on the position of the position indicator 1402. Such relevant information known to the tracker 1410 for determining the position of the tibial implant 10 may be stored in an implant database and / or taught to the tracker, as described above.
[0117] After the tracker 1410 determines the position of the tibial implant 10, the process is roughly the same as the process described in the above-mentioned embodiment.The tracker 1410 determines or is notified of the position of tibia T.Then the position of the tibial implant 10 is compared relative to the position of tibia T, so as to verify whether the tibial implant is moving towards the correct position on the proximal end PE of tibia.When using the position verification system 1400 during the placement or implantation of the tibial implant 10 on tibia T, the tracker 1410 or the surgeon can compare the position of the tibial implant relative to the ideal position, to verify that the tibial implant is moving (for example, in line with the ideal position) towards the ideal position (because the tibial implant is implanted on the proximal end PE of tibia T).If the tibial implant 10 is moving towards the ideal position, the surgeon can continue to move the tibial implant 10 towards tibia T (for example, insert) and make it enter the tibia, without any adjustment.If the tibial implant is not moved towards the ideal position, the surgeon can make necessary adjustments and corrections while the tibial implant 10 is moved towards tibia T and made to enter the tibia. In this manner, the position verification system 1400 guides the tibial implant 10 toward the ideal position.
[0118] In another exemplary method, after tibial implant is implanted on tibia T, implant covering 1422 is connected to tibial implant 10, to verify the position of tibial implant relative to tibia. In this embodiment, the surgeon will attach the implant covering 1422 with position indicator 1402 to the tibial implant 10 implanted in tibia T (for example, the surgeon positions the position indicator relative to the tibial implant). Tracker 1410 tracks position indicator 1402 to determine the position of tibial implant 10. Tracker 1410 tracks or locates the position of the position indicator 1402 installed on the implant covering 1422 that is connected to tibial implant 10. Tracker 1410 locates position indicator 1402 to determine or infer the position of tibial implant 10. As mentioned above, tracker 1410 knows the geometry of tibial implant 10, the geometry of implant covering 1422 (comprising the position of position indicator 1402 relative to implant covering) and the relative orientation and the position of tibial implant and implant covering when implant covering is attached to tibial implant. Tracker 1410 uses this information to determine the position of tibial implant 10 based on the position of position indicator 1402.
[0119] After the tracker 1410 determines the position of the tibial implant 10, the process is roughly the same as the process described in the above-mentioned embodiment. The tracker 1410 determines or is notified of the position of tibia T. The position of the tibial implant 10 is then compared relative to the position of tibia T, so as to verify whether the tibial implant is correctly positioned on the proximal end PE of the tibia. When the position verification system 1400 is used to verify the position of the tibial implant 10 relative to tibia T after the implant is implanted, the tracker 1410 or the surgeon can compare the position of the tibial implant relative to the ideal position, to verify or confirm the correct position of the tibial implant on the tibia. If the position of the tibial implant 10 relative to the position of tibia T is aligned with the ideal position, the tibial implant is correctly positioned and the surgeon can proceed to the remainder of the surgical operation. If the position of the tibial implant 10 relative to the position of tibia T is not aligned with the ideal position, the surgeon adjusts the position of the implant as needed before proceeding with the surgical operation. After verifying the position of the tibial implant 10, the implant cover 1422 can be removed or disengaged from the implant. These same procedures can be used to determine the position of other implants relative to the bone. Fig.35 As shown, the same process can be used to verify the position of the femoral implant 11 by tracking the position indicator 1403 of the position verification system 1400 mounted on the implant cover 1422 connected to the femoral implant.
[0120] The order of performing or executing operations in the embodiments of the various aspects of the disclosure described herein is not necessary unless otherwise specified or otherwise indicated. That is, operations can be performed in any order and / or performed simultaneously, and the embodiments of the various aspects of the disclosure may include operations more or less than those disclosed herein. For example, it is conceivable that performing or executing a particular operation before, simultaneously with, or after another operation is also within the scope of the disclosure.
[0121] The tracking systems and methods described herein can also be used to determine the position of other elements and objects other than implants. In one embodiment, the tracking systems and methods described herein are used to determine the position of the bone to which the implant is attached. For example, in a Fig.30 and Fig.31 In an embodiment similar to that shown in , the surgeon may rub or move a position indicator 1402 (eg, the tip of a stylus) over all or a portion of the tibia T or its proximal end PE to determine the position of the tibia.
[0122] refer to Figure 36 to Figure 46, a patella implant according to another embodiment of the present disclosure is generally indicated by reference numeral 1510. The size and shape of the patella implant 1510 are set to be suitable for implantation into the back of the patient's patella. The patella implant 1510 includes a proximal or articulating surface 1514 (e.g., a proximal end) and an opposing distal surface 1516 (e.g., a distal end). The distal surface 1516 is configured to engage the back of the patella. The articulating surface 1514 has a partial dome shape. As discussed above, the patella implant 1510 includes a porous area. Specifically, the distal surface 1516 is porous (e.g., a porous area). In the illustrated embodiment, a portion of the distal surface 1516 is porous, but in other embodiments, the entire distal surface 1516 may be porous. The porous portion of the distal surface 1516 is approximately located at the center of the distal surface and is spaced apart from the peripheral edge of the distal surface. The porous region has a generally circular shape disposed within the larger circular shape of the distal surface 1516. As shown in the illustrated embodiment, the porous region includes generally hexagonal struts coupled together to form a lattice, but any suitable porous structure is also within the scope of the present disclosure. As mentioned above, the porosity of the distal surface 1516 allows the patella implant 1510 to be inserted into or implanted on the patella without the cement conventionally used in knee arthroplasty, thereby reducing surgical time, cement-related complications, and surgeon stress.
[0123] The patella implant 1510 includes a cover 1550 and a base or anchor 1552 that are coupled or fixed together. The cover 1550 is mounted on the base 1552. The cover 1550 defines (e.g., includes) an articulation surface 1514. The cover 1550 also defines a portion of a distal surface 1516. In the illustrated embodiment, the portion of the distal surface 1516 defined by the cover 1550 is not porous. The cover 1550 includes a shield or covering 1551. The shield 1551 includes the articulation surface 1514. The shield 1551 has a partial dome shape and defines an interior or cavity that is sized and shaped to receive a portion of the base 1552, as described in more detail below. The shield 1551 surrounds (e.g., covers) the proximal end portion of the base 1552. The cover 1550 can be made of a polymer material or any other suitable material.
[0124] The base 1552 is configured to be attached to the back of the patient's patella. The base 1552 includes at least one (e.g., multiple) anchoring protrusions 1534 similar to the anchoring protrusions discussed above. The anchoring protrusions 1534 are configured to be inserted into the back of the patella. In the illustrated embodiment, the patella implant 1510 includes three anchoring protrusions 1534, but more or less anchoring protrusions are also within the scope of the present disclosure. Each anchoring protrusion 1534 extends generally distally from the distal surface 1516. Specifically, the anchoring protrusions 1534 extend from the cover support 1554, which is described in more detail below. In this embodiment, each anchoring protrusion 1534 is cylindrical (e.g., having a cylindrical shape) with an oblate conical distal tip 1536. The anchoring protrusions 1534 are also solid, but in other embodiments, the anchoring protrusions may be hollow. Additionally, the base 1552 defines a portion of the distal surface 1516. In the illustrated embodiment, the portion of the distal surface 1516 defined by the base 1552 is porous (see Fig.48 ). This allows bone to grow inwardly into the base 1552 to further secure the base to the patella after the base is attached to the patella. Therefore, when the patella implant 1510 is attached to the patella, the distal surface 1516 faces and engages the patella. Therefore, the porous area of the base 1552 is configured to face the back of the patella. The base 1552 can be made of metal or any other suitable material.
[0125] The cover 1550 and the base 1552 are coupled (e.g., configured to be coupled) together to form the patella implant 1510. The base 1552 includes a base support 1554, which is mounted to the cover 1550 (e.g., configured to be attached to the cover). Specifically, the base support 1554 is mounted to the shield 1551 of the cover 1550. The base support 1554 is disposed inside the shield 1551, and the size and shape of the shield are set to receive the base support. In order to fix the cover 1550 and the base 1552 together, the cover and the base include a plurality of interconnected or staggered engagement members. The interconnected members of the cover 1550 and the base 1552 cooperate and interlock with each other to fix the cover and the base to each other. Compared with conventional patella implants, the multiple interconnected members of the cover 1550 and the base 1552 increase the resistance of the cover and the base from dislocation from each other and minimize the occurrence and intensity of micro-motion. The cover support 1554 also provides rigidity to the patella implant 1510 and provides a mounting platform for the porous structure (eg, hexagonal struts) and the anchoring protrusions 1534 .
[0126] refer to Figures 38 to 46, the interconnecting members of the cover 1550 include a plurality of first connecting members 1560 (e.g., first protrusions). Similarly, the interconnecting members of the base 1552 include a plurality of first connecting recesses 1562. Each first connecting member 1560 of the cover 1550 is disposed (e.g., configured to be disposed) in a corresponding one of the first connecting recesses 1562 of the base 1552 to mount and secure the cover to the base (e.g., the first connecting recess receives or is configured to receive the first connecting member). The first connecting members 1560 are spaced apart and extend from the inner surface of the shield 1551 to the interior of the shield. The cover support 1554 includes (e.g., defines) the first connecting recess 1562. The first connecting recess 1562 extends generally inwardly from the outer surface of the cover support 1554. The outer surface of the cover support 1554 and the inner surface of the shield 1551 correspond to and engage with each other ( Fig.42 ). In the embodiment shown, the outer surface and the inner surface have a generally partial dome shape.
[0127] Each first connection member 1560 of the cover 1550 is interlocked with a corresponding first connection recess 1562 of the base 1552 (e.g., configured to interlock). Specifically, the sizes and shapes of the first connection member 1560 and the first connection recess 1562 correspond to each other. The first connection recess 1562 is each undercut (in one or more directions) to prevent the extraction of the first connection member 1560 disposed therein. In the illustrated embodiment, each first connection recess 1562 includes a recess mouth 1564 and a recess base or bottom plate 1566 opposite to the recess mouth. The recess mouth 1564 (e.g., its area and / or diameter) is smaller than or narrower than the recess base 1564 (e.g., its area and / or diameter). Each first connection recess 1562 is at least partially defined by at least one cover support conical surface 1568 (e.g., first cover support conical surface). In the illustrated embodiment, the first connection recess 1562 includes a cap support tapered surface 1568, but other configurations are also within the scope of the present disclosure. As the cap support tapered surface extends inward, the cap support tapered surface 1568 tapers outward. In the illustrated embodiment, the cap support tapered surface 1568 extends inward from the recess mouth 1566 (e.g., the outer surface of the cap support 1554). Correspondingly, in the illustrated embodiment, each first connection member 1560 includes a free or connection end 1570 opposite to the attachment end 1572. The attachment end 1572 is attached to the shield 1551 (e.g., its inner surface). The attachment end 1572 (e.g., its cross-sectional area and / or diameter) is smaller or narrower than the connection end 1570 (e.g., its cross-sectional area and / or diameter). The attachment end 1572 of each first connection member 1560 corresponds to the size and shape of the recess mouth 1564 of the corresponding first recess member 1562. Likewise, the connection end 1570 of each first connection member 1560 corresponds to the size and shape of the recess base 1566 of the corresponding first recess member 1562. Each first connection member 1560 includes at least one connection member tapered surface 1574 (e.g., a first connection member tapered surface). In the illustrated embodiment, the first connection member 1560 includes one connection member tapered surface 1574, but other configurations are also within the scope of the present disclosure. The connection member tapered surface 1574 is disposed between the connection end 1570 and the attachment end 1572. As the connection member tapered surface extends away from the shield 1551 (e.g., the inner surface of the shield), the connection member tapered surface 1574 tapers outwardly. In the illustrated embodiment, the connection member tapered surface 1574 extends from the shield 1551 (e.g., its inner surface). The connecting member tapered surface 1574 and the cover support tapered surface 1568 engage (eg, are configured to engage each other) to connect the cover 1550 and the base 1552 together and prevent withdrawal of the corresponding first connecting member 1560 from the corresponding first connecting recess 1562 .In the illustrated embodiment, the first connection member 1560 and the first connection recess 1562 have a generally frustoconical shape.
[0128] Still refer to Figures 38 to 44 , the interconnection member of the cover 1550 further includes a plurality of second connection members 1576 (e.g., second protrusions). Similarly, the interconnection member of the base 1552 includes a plurality of second connection recesses 1578. Each second connection member 1576 of the cover 1550 is disposed (e.g., configured to be disposed) in a corresponding one of the second connection recesses 1578 of the base 1552 to mount and fix the cover to the base (e.g., the second connection recess receives or is configured to receive the second connection member). The second connection members 1576 are spaced apart and extend from the inner surface of the shield 1551 to the interior of the shield. The second connection members 1576 are disposed along the peripheral edge (e.g., the inner peripheral edge) of the cover 1550 (e.g., the shield 1551). The second connection members 1576 are circumferentially spaced apart along the peripheral edge of the shield 1551. Therefore, the second connection members 1576 are generally disposed on the outside (e.g., radially outside) of the first connection member 1560 (e.g., the first connection member is generally disposed on the inside of the second connection member). The cover support 1554 includes a second connection recess 1578. The second connection recess 1578 is disposed along a peripheral edge (e.g., an outer peripheral edge) of the cover support 1554. The second connection recesses 1578 are circumferentially spaced apart along the peripheral edge of the cover support 1554. Thus, the second connection recess 1578 is disposed substantially outside (e.g., radially outside) the first connection recess 1562 (e.g., the first connection recess is disposed substantially inside the second connection recess).
[0129] Each second connection member 1576 of the cover 1550 is connected to a corresponding one of the second connection recesses 1578 of the base 1552 (e.g., configured to interlock). Specifically, the sizes and shapes of the second connection members 1576 and the second connection recesses 1578 correspond to each other. As with the first connection recesses 1562, the second connection recesses 1578 are each undercut (in one or more directions) to prevent the extraction of the second connection members 1576 disposed therein. Obviously, the second connection member 1576 has a different shape from the first connection member 1560. Similarly, the second connection recess 1578 has a different shape from the first connection recess 1562.
[0130] In the illustrated embodiment, each second connection recess 1578 includes a recess mouth 1580 and a recess base or floor 1582 opposite the recess mouth. In the illustrated embodiment, the recess mouth 1580 has a generally hourglass shape. The generally hourglass shape of the recess mouth 1580 is generally bent at the corner of the cover support 1554. Similarly, the recess base 1582 has a generally hourglass shape that is also bent. The recess mouth 1580 (e.g., its area) is smaller than or narrower than the recess base 1582 (e.g., its area). Each second connection recess 1578 is at least partially defined by a plurality of cover support tapered surfaces 1584 (e.g., second cover support tapered surfaces). As the cover support tapered surfaces extend inwardly, each cover support tapered surface 1568 tapers outwardly. The cover support tapered surface 1568 tapers outwardly along a plurality of different outward directions. In the illustrated embodiment, each cap support tapered surface 1584 extends inwardly (e.g., generally radially inwardly) from the recess mouth 1580 (e.g., the outer surface of the cap support 1554). Each cap support tapered surface 1584 defines one side of the second connection recess 1578. Correspondingly, in the illustrated embodiment, each second connection member 1576 includes a free or connection end 1586 opposite the attachment end 1588. The attachment end 1588 is attached to the shield 1551 (e.g., its inner surface). The attachment end 1588 (e.g., its cross-sectional area) is smaller or narrower than the connection end 1586 (e.g., its cross-sectional area). The attachment end 1588 of each second connection member 1576 corresponds to the size and shape of the recess mouth 1580 of the corresponding second recess member 1578. Similarly, the connection end 1586 of each second connection member 1576 corresponds to the size and shape of the recess base 1582 of the corresponding second recess member 1578. Each second connection member 1576 includes a plurality of connection member tapered surfaces 1590 (e.g., second connection member tapered surfaces). Each connection member tapered surface 1590 is disposed between the connection end 1586 and the attachment end 1588. As the connection member tapered surface extends into the cover support 1554 (e.g., the outer surface of the cover support), each connection member tapered surface 1590 tapers outwardly. In the illustrated embodiment, each connection member tapered surface 1590 extends from the outer surface of the cover support 1554. Each connection member tapered surface 1590 engages the corresponding cover support tapered surface 1584 to connect the cover 1550 and the base 1552 together and prevent the corresponding second connection member 1576 from being withdrawn from the corresponding second connection recess 1578.
[0131] refer to Fig.39 and Figures 44 to 46, the interconnection member of the cover 1550 further includes a plurality of interconnection struts 1592. Each interconnection strut 1592 extends between two adjacent second connecting members 1576 and interconnects the two adjacent second connecting members. Similarly, the interconnection member of the base 1552 further includes a plurality of interconnection voids 1594. Each interconnection void 1594 extends between two adjacent second connecting recesses 1578 and interconnects the two adjacent second connecting recesses. Each interconnection strut 1592 of the cover 1550 is disposed (e.g., configured to be disposed) in a corresponding one of the interconnection voids 1594 of the base 1552 to further mount and secure the cover to the base (e.g., the interconnection void receives or is configured to receive an interconnection strut). Therefore, as Fig.45 As shown, the interconnecting braces 1592 and the second connecting member 1576 are combined to form a continuous ring that surrounds a portion of the base 1552 (e.g., the cover support 1554). The continuous ring formed by the interconnecting braces 1592 and the second connecting member 1576 is limited by the cover support 1554 and cannot move relative to the base 1552. Therefore, like the separate first connecting member 1560 and the second connecting member 1576, the continuous ring formed by the interconnecting braces 1592 and the second connecting member fixes and interlocks the cover 1550 and the base 1552 together and prevents the cover from moving relative to the base.
[0132] Other configurations of the interconnecting members of the cover 1550 and the base 1552 and other ways of attaching the cover and base together are also within the scope of the present disclosure.
[0133] The patella implant 1510 can be constructed using the manufacturing techniques and processes discussed herein. The base 1552 can be constructed using hybrid manufacturing. In the hybrid manufacturing process, the cover support 1554 and the anchoring protrusion 1534 can first be produced or formed by conventional manufacturing methods such as cold forming (e.g., stamping, cutting, deformation) of a metal blank or by forging. The partially formed base 1552 is then placed in an additive manufacturing machine, which builds a porous area on the base (e.g., on the cover support 1554). In other embodiments, the base 1552 can be formed entirely by an additive manufacturing process. After the base 1552 is formed, the cover 1550 is then attached to the base (e.g., formed on the base) to complete the construction of the patella implant 1510. The polymer cover 1550 can be formed by conventional methods (such as compression molding).
[0134] For example, one method of forming the patella implant 1510 involves forming a base 1552 (and associated elements, such as interconnecting members, anchoring protrusions 1534, etc.), and then molding (e.g., compression molding) a material (e.g., a polymer material) onto the base (e.g., a cover support 1554) to form a cover 1550 having an articulating surface 1514. The molding includes substantially (if not completely) filling the first connection recess 1562 with material to form the first connection member 1560. Similarly, the molding includes substantially (if not completely) filling the second connection recess 1578 with material to form the second connection member 1576. In addition, the molding includes substantially (if not completely) filling the interconnection void 1594 with material to form the interconnection strut 1592.
[0135] refer to Figures 47 to 50 Another embodiment of a patellar implant according to the present disclosure is generally indicated at 1610 ( Fig.50 In this embodiment, the configuration of the base 1652 of the patella implant 1610 is different from Figure 36 to Figure 46 The configuration of the base 1552 of the patella implant 1510 (wherein the configuration of the cover 1650 is the same as Figure 36 to Figure 46 1550 is substantially the same as the cap 1550 of the present invention). In this embodiment, the porous region of the base 1652 protrudes distally from the cap support 1654. In other words, the portion 1616A of the distal surface 1616 defined by the porous region protrudes distally from the portion 1616B of the distal surface defined by the cap 1650. This ensures maximum contact of the porous region with the bone to promote bone ingrowth into the porous region. In addition, in this embodiment, the anchoring protrusions 1634 each include a porous region. In the embodiment shown, the porous region extends approximately over the entire outer surface of the anchoring protrusion 1634, but other configurations are also within the scope of the present disclosure. For example, the porous region may extend only over a portion of the anchoring protrusion (e.g., only along the side). In the embodiment shown, the porous region of the anchoring protrusion 1634 is continuous with the porous region of the portion 1616A of the base 1652 that defines the distal surface 1616. The anchoring protrusions 1634 and the porous region of the base may have similar configurations and porosities (as shown) or different configurations and porosities.
[0136] In addition, in this embodiment, the anchoring protrusion 1634 is hollow (e.g., having a hollow core). The base 1652 defines an elongated cavity 1633 for each anchoring protrusion 1634. Each elongated cavity 1633 extends from the outer surface of the cover support 1654 through the cover support and into the anchoring protrusion 1634. The distal end of the elongated cavity 1633 is adjacent to the distal end 1636 of the anchoring protrusion 1634. In the embodiment shown, the distal end of the elongated cavity 1633 is closed. In other embodiments, the elongated cavity 1633 may extend through the anchoring protrusion 1634 (e.g., having an open distal end). The elongated cavity 1633 reduces the amount of material required to construct the base 1652, thereby reducing manufacturing costs compared to solid anchoring protrusions. In addition, the elongated cavity 1633 forms another interconnecting member of the base 1652 for further fixing the cover 1650 to the base 1652. In this embodiment, cover 1650 may include elongated members or shafts (not shown), wherein each elongated member is disposed (e.g., configured to be disposed) in a corresponding one of elongated cavities 1633. The elongated members of cover 1650 may be formed by molding (e.g., during molding), as described herein.
[0137] refer to Fig.51 and Fig.52 Another embodiment of a patellar implant according to the present disclosure is generally indicated at 1710. In this embodiment, a base 1752 of the patellar implant 1710 is connected to the Figures 36 to 46 The base 1552 is substantially the same as the base 1552, except that the porous region of the base 1752 protrudes distally from the cover support 1754, and Figures 47 to 50The same as the base 1652 of the anchoring projection 1734. In addition, each anchoring projection 1734 includes a bone connection structure 1796 (except the porous area) located outside the projection to promote the connection between the bone and the anchoring projection. The bone connection structure 1796 generally increases the surface area of the anchoring projection 1734 to increase the contact amount between the bone and the anchoring projection, thereby increasing the connection strength between the bone and the anchoring projection. In the illustrated embodiment, the bone connection structure 1796 includes a ridge separated by a groove, and these ridges extend along the outer surface of each anchoring projection 1734. The grooves defining the ridges enhance the pressure fit with the bone by providing a relief for bone to be pressed into. The ridges and grooves generally extend axially along the anchoring projection 1734. The size (e.g., width) of the grooves and / or ridges can remain unchanged (as shown) along the length of the anchoring projection 1734, or can change along the length of the anchoring projection. Other sizes (e.g., depth, diameter, etc.) of the ridges and / or grooves can also change or remain unchanged. In the illustrated embodiment, the ridges and grooves are large enough to be visible to the human eye, but in other embodiments, the ridges and / or grooves can be significantly smaller so that they cannot be observed by the human eye (e.g., visible with a microscope). Other configurations of the bone connection structure are also within the scope of the present disclosure. For example, the bone connection structure can include spherical dimples, similar to a golf ball. In yet another example, the bone connection structure can include a rough outer surface of the anchoring protrusion 1734.
[0138] refer to Fig.53 Another embodiment of a base of a patellar implant according to the present disclosure is generally indicated at 1852. In this embodiment, the base 1852 is connected to the patellar implant. Figures 47 to 50 The base 1652 is substantially the same as that of the embodiment of the present invention, except that the anchoring protrusion 1834 does not have a porous area (such as Figures 47 to 50 As will be apparent, the cover can be connected to the base 1852 to form a patella implant (not shown), as described herein.
[0139] refer to Figure 54 to Figure 57 Another embodiment of a patella implant according to the present disclosure is generally indicated at 1910. In this embodiment, in addition to the configuration of the bone connection structure, the base 1952 of the patella implant 1910 is connected to the Fig.51 and Fig.52The base 1752 of the anchoring protrusion 1934 is substantially the same. In this embodiment, the bone connecting structure 1996 includes a dovetail groove (e.g., a plurality of dovetail grooves). In one embodiment, each dovetail groove may be tapered (in one or more directions) along the anchoring protrusion 1934. In the illustrated embodiment, as the dovetail groove extends away from the porous area of the base 1952 along the anchoring protrusion 1934, each dovetail groove tapers in depth (e.g., narrows). In addition, in the illustrated embodiment, as the dovetail groove extends away from the porous area of the base 1952 along the anchoring protrusion 1934, each dovetail groove tapers in width (e.g., narrows). In another embodiment, each dovetail groove may maintain a constant size along the length of the anchoring protrusion 1934. In yet another embodiment, as the dovetail groove extends away from the porous area of the base 1952 along the anchoring protrusion 1934, each dovetail groove may taper in depth and / or width (e.g., widens). In yet another embodiment, each dovetail groove can have one or more dimensions (e.g., depth, width, etc.) that remain constant and one or more dimensions (e.g., depth, width, etc.) that taper (e.g., narrow or widen) as the dovetail groove extends along the anchoring protrusion 1934 away from the porous region of the base 1952. For example, the depth of the dovetail groove can remain constant while the width tapers, or vice versa. In the embodiment shown, the bottom or base of the dovetail groove is rounded or curved. In another embodiment, the bottom of the dovetail groove can be generally flat or planar.
[0140] It is obvious that implant 10,110,210,310,410,510,610,710,810,910,1010,1110,1310,1510,1610,1710,1910 disclosed herein are roughly similar to each other, and therefore for ease of understanding, in the case of using similar or similar parts between various implants (or its element, such as base 1552,1652,1752,1852 and 1952), adopt the figure number with identical last two digits.For example, tibial keel 28 is similar to tibial keel 228, and therefore these two tibial keels have identical last two digits " 28 ".In another example, base 1852 is similar to base 1652, and therefore these two bases have identical last two digits " 52 ".Therefore, unless clearly stated or indicated in addition, otherwise the above description about implant and element thereof is equally applicable to all similar implants and element thereof. For example, at least some of the descriptions related to anchoring protrusion 34 may also apply to anchoring protrusion 134 and / or vice versa. In another example, at least some of the descriptions related to base 1552 may also apply to base 1852 and / or vice versa.
[0141] It is obvious and should be understood that the elements, features and / or teachings set forth in each embodiment disclosed herein are not limited to the specific embodiments in which these elements, features and / or teachings are described. Therefore, it is obvious and should be understood that the elements, features and / or teachings described in one embodiment can be applied to one or more embodiments in other embodiments disclosed herein. For example, it should be understood that any tibial keel disclosed herein can have sharp edges present on the tibial keel 128. In another example, the methods and features of a position verification method can be used together with another position verification method.
[0142] Modifications and changes may be made to the disclosed embodiments without departing from the scope of the present disclosure as defined in the following claims.
[0143] When introducing elements of the present disclosure or embodiments thereof, the articles "a," "an," "the," and "said" are intended to indicate that there are one or more elements. The terms "comprising," "including," and "having" are intended to be inclusive and mean that there may be additional elements other than the listed elements.
[0144] As various changes could be made in the above constructions, products and methods without departing from the scope of the disclosure, it is intended that all matter contained in the above description and shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense.
Claims
1. A patella implant for knee arthroplasty, the patella implant comprising: a cover including a hinged surface, the cover having a first plurality of connecting members; as well as a base configured to be attached to a back surface of a patient's patella, the base comprising a cover support mounted to the cover, the cover support comprising a plurality of first connection recesses, wherein each first connection member of the cover is disposed in a corresponding one of the first connection recesses of the cover support to mount the cover to the base, wherein each first connection member of the cover interlocks with the corresponding one of the first connection recesses of the cover support, Each of the first connecting recesses has a recess opening opposite to the recess base, and the recess opening is smaller than the recess base, wherein the cover comprises a plurality of second connection members, and the cover support of the base comprises a plurality of second connection recesses, wherein each second connection member of the cover is disposed in a corresponding one of the second connection recesses of the cover support to mount the cover to the base, wherein the second connecting member has a shape different from that of the first connecting member, and the second connecting recess has a shape different from that of the first connecting recess, The second connecting member is arranged along the peripheral edge of the cover, and the first connecting member is arranged on the inner side of the second connecting member.
2. The patella implant of claim 1 , wherein each first connecting member has a connecting end opposite to the attachment end, each attachment end is smaller than the corresponding connecting end, and wherein each connecting end corresponds to the size and shape of the recess base, and each attachment end corresponds to the size and shape of the recess mouth.
3. The patella implant of claim 2, wherein the first connection member includes at least one connection member tapered surface disposed between the connection end and the attachment end.
4. A patella implant according to claim 3, wherein each first connecting recess is at least partially defined by at least one cover support conical surface of the cover support, and wherein each connecting member conical surface engages the corresponding cover support conical surface to prevent the corresponding first connecting member from being withdrawn from the corresponding first connecting recess. 5 . The patella implant according to claim 1 , wherein the second connection recess is provided along a peripheral edge of the base and the first connection recess is provided at an inner side of the second connection recess.
6. A patella implant according to claim 1, wherein the cover support includes a plurality of interconnected voids, each interconnected void extending between two adjacent second connection recesses and interconnecting the two adjacent second connection recesses, and wherein the cover includes a plurality of interconnected struts, each interconnected strut extending between two adjacent second connection members and interconnecting the two adjacent second connection members, each interconnected strut being arranged in a corresponding one of the interconnected voids.
7. The patella implant of claim 1, wherein the base further comprises at least one anchoring protrusion configured to be inserted into the back surface of the patella.
8. The patella implant of claim 7, wherein the at least one anchoring projection comprises a porous region.
9. The patella implant of claim 1, wherein the base includes a porous area configured to face the back surface of the patella when the base is attached to the patella to enable bone ingrowth into the base after the base is attached to the patella.
10. The patella implant of claim 9, wherein the porous region protrudes distally from the cap support.
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