Inserts for knee prostheses

Abstract

An insert (150) for use in a knee prosthesis (100) is disclosed. In one embodiment, the insert includes a medial compartment (260) and a lateral compartment (270). The medial compartment includes a top surface (262) having a concave or curved surface with a rearward groove (Pm) and an increased anterior lip (265). The lateral compartment includes a top surface (272) having at least a segment or portion with a convex or curved surface. This arrangement provides improved stability for different grades of PCL defects compared to existing inserts with a midline groove and a lateral convexity. Furthermore, this insert provides improved lateral posterior translation compared to existing designs with concave or flat lateral joints lacking a lateral posterior convexity.

Description

[0001] Cross-references to related applications

[0002] This application is a non-provisional application filed on September 24, 2020, entitled “Insert for Use in a Knee Prosthesis”, U.S. Provisional Patent Application No. 63 / 082,759, and claims the benefit of the filing date thereof, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This disclosure relates to an orthopedic implant, and more specifically to an insert for use in an orthopedic knee prosthesis. Background Technology

[0004] Knee arthroplasty or knee replacement surgery typically involves the implantation, placement, or mounting (these terms are used interchangeably but are not intended to limit) of an orthopedic implant, such as a knee prosthesis, onto a patient's knee. For example, in combination with total knee arthroplasty or knee replacement (“TKA”), the orthopedic implant (e.g., a knee prosthesis) may include a femoral component and a tibial component. In use, the femoral component is attached to the patient's femur, while the tibial component is attached to the patient's tibia. Generally, both the femoral and tibial components may include support members, such as intramedullary rods, trays, load-bearing components, etc., which may be attached to the joint components (these terms are used interchangeably herein and are not intended to limit). In use, the support member is arranged and configured to engage with the patient's bone and may be inserted, for example, into the intramedullary canal of the patient's bone, while the tray is mounted on a prepared surface on the patient's bone. The load-bearing component or insert is typically mounted on the tray of the tibial component.

[0005] TKA (Total Knee Replacement) can be performed to address damage in multiple compartments of the knee joint caused by factors such as arthritis. TKA aims to alleviate chronic pain within the joint and restore function to the disabled knee. Early knee prostheses tended to focus primarily on stabilizing the knee through guided movement, largely neglecting the patient's natural ligament structures. However, with advancements in joint replacement surgery and improvements in implant fixation, new designs have emerged that work in conjunction with the patient's soft tissue structures, enabling increased femoral freedom of movement relative to the tibia while providing varying degrees of stability based on the patient's specific needs and the surgeon's preferences.

[0006] Currently, knee prostheses can be grouped into four main classification types based on how the cruciate ligaments are managed. The posterior stabilization (“PS”) design sacrifices both cruciate ligaments of the patient's knee, replacing the posterior cruciate ligament (“PCL”) with a cam and column mechanism that helps control anterior translation during knee flexion. The cruciate ligament sacrifice (“CS”) and deep disc (“DD”) design also allows for the removal of both cruciate ligaments while providing a more conforming joint geometry to aid joint stability. The cruciate ligament preservation (“CR”) design sacrifices only the anterior cruciate ligament while preserving the PCL, aiming to provide anterior / posterior (A / P) stability to the femur when it flexes relative to the tibia, while the less conforming joint geometry allows for increased voluntary movement. The fourth type of TKA is the double cruciate ligament preservation (“BCR”) design, which preserves both cruciate ligaments and provides limited conformity and geometric constraints, thus relying solely on soft tissue structures to drive the knee's kinematics. Although BCR knee prostheses offer the theoretical advantage of achieving more normal kinematics, their use remains quite limited because many surgeons have not yet adopted the more advanced surgical techniques required to perform such procedures. Therefore, most TKA surgeries currently performed continue to use PS or CR knee prostheses.

[0007] While PS designs tend to promote more reliable kinematics compared to most CR designs, there is an increasing trend towards preserving the patient's native bone by avoiding the need to resection the box-shaped geometry of the PS femoral component. Consequently, more surgeons are seeking implants with designs such as CR and CS that allow for bone preservation while still providing adequate A / P restraint with reliable kinematics. Furthermore, surgeons who can typically perform TKA with CR-type implants may experience situations where the preserved PCL does not provide acceptable A / P restraint when using many more standard joint CR inserts. If the PCL is found to be non-primitive, this may be apparent during surgery or may occur postoperatively as the PCL begins to loosen and becomes lax within the joint. On the other hand, the choice of using CS and DD inserts is less desirable unless the patient requires additional restraint, because the more conforming joint geometry may prohibit condylar movement that promotes kinematics to improve knee flexion.

[0008] Currently, surgeons who typically use PS implants for TKA are increasingly using CR and CS / DD knee prostheses. This shift in surgical philosophy is supported by a number of CR / CS and DD type knee prostheses currently available on the market that meet the need for bone protection and provide increased stability even after removal of both cruciate ligaments. These implant systems have facilitated the use of specialized articular inserts with different joint compliance and characteristics. One existing design is the medial pivot knee, which utilizes a groove in the medial compartment of the articular insert that closely conforms to the geometry of the medial femoral condyle. This geometry helps prevent the femur from sliding forward on the tibia. Other existing designs achieve concave or cup-shaped geometries in the medial and lateral compartments of the articular insert. These choices also tend to provide a more conforming fit, matching the medial and lateral femoral condyles at a defined flexion angle to promote increased A / P stability.

[0009] Nevertheless, it would be beneficial to provide a joint insert for CR knee prostheses that provides appropriate A / P constraints regarding the condition of the remaining natural soft tissue structures, while achieving reliable kinematics that promote improved knee function.

[0010] It is with this in mind that this disclosure is made. Summary of the Invention

[0011] This invention is provided to introduce a series of concepts in a simplified form, which will be further described in the detailed description section below. This invention is not intended to identify key or essential features of the claimed subject matter, nor is it intended to help determine the scope of the claimed subject matter.

[0012] In one embodiment, an insert suitable for use in a knee prosthesis is disclosed. In one embodiment, the joint insert is arranged and configured for use in conjunction with an existing knee prosthesis (e.g., an existing TKA CR femoral component), which, in combination with soft tissue structures, provides improved stability superior to existing CR insert designs, while promoting kinematics within the lateral compartment, which helps to facilitate improved rotational movement and flexion of the knee compared to existing CS / DD insert designs.

[0013] In one embodiment, the insert includes a generally concave medial compartment and a convex lateral compartment. That is, in one embodiment, the insert includes a medial compartment for contacting a medial condylar surface formed on a femoral member or bone and a lateral compartment for contacting a lateral condylar surface on a femoral member or bone. The medial compartment includes a top surface having a generally concave or curved surface. The lateral compartment includes a top surface having a composite curved surface, said composite curved surface having at least a portion or segment including a generally convex or curved surface.

[0014] This arrangement, in use, positions the medial groove of the articular insert substantially further posteriorly, allowing for an increased anterior lip with a fully concave geometry that closely matches the geometry of the medial femoral condyle of the femoral component in the contact area of ​​the femur. Therefore, the medial compartment provides sufficient medial restraint for PCL defects and sacrificial conditions. Combined with the concave medial compartment providing additional stability, the lateral compartment is optimized with an anterior concave portion with a relaxed anterior lip to allow for spiral return during extension. This lateral anterior concave portion transitions into a reverse profile convex portion with an increased slope along the posterior half of the articular surface to facilitate lateral posterolateral translation, while also contributing to lateral rotation of the femur relative to the tibia as the knee moves into deeper flexion.

[0015] In one embodiment, an insert suitable for use in a knee prosthesis including a femoral component and a tibial component is disclosed. The insert includes an anterior surface, a posterior surface, a medial surface, a lateral surface, a top surface, a bottom surface, a medial compartment, and a lateral compartment. In use, the medial compartment is arranged and configured to interact with the medial condylar surface of the femoral component. The lateral compartment is arranged and configured to interact with the lateral condylar surface of the femoral component. In one embodiment, the medial compartment includes a concave top surface for contacting the medial condylar surface of the femoral component, while the lateral compartment includes a top surface having a composite curved surface having at least a convex top segment for contacting the lateral condylar surface of the femoral component.

[0016] In one embodiment, the concave top surface of the inner compartment includes an inner groove point positioned closer to the rear surface than the front surface.

[0017] In one embodiment, the inner groove point is located at a distance D from the rear surface of the insert, where distance D is approximately 35% to 40% of the total distance between the rear and front surfaces of the insert.

[0018] In one embodiment, the front surface includes a front lip and a rear lip, the front lip having a height H measured from the inner groove point to the tip of the front lip. A The posterior lip has a height H measured from the inner groove point to the tip of the posterior lip. p The height H A Greater than height H p .

[0019] In one embodiment, the height H at the front lip A Between 6.5mm and 10mm.

[0020] In one embodiment, the height H at the posterior lip p Between 3mm and 4mm.

[0021] In one embodiment, the concave top surface extends completely from the rear surface to the front surface.

[0022] In one embodiment, the composite top surface of the outer compartment includes a front recess (e.g., a front section including a concave surface) that transitions to a reverse profile protrusion (e.g., a protruding section).

[0023] In one embodiment, the composite top surface includes a recessed rear section located between the rear surface of the insert and the convex top section.

[0024] In one embodiment, the composite top surface includes a recessed middle section located between the recessed rear section and the convex top section.

[0025] In one embodiment, the composite top surface includes a recessed section located between the front surface of the insert and the convex top section.

[0026] In one embodiment, the composite top surface includes a flat section located between the concave section and the convex top section.

[0027] In one embodiment, the composite top surface of the outer compartment includes an outer groove point defined as a transition between a concave section and a flat section (e.g., the outer groove point is located at the transition between the concave section and the flat section).

[0028] In one embodiment, the composite top surface of the outer compartment includes an outer groove point at the rearmost end of the concave section (e.g., the outer groove point is located at the rear end of the concave section).

[0029] In one embodiment, the outer groove point is located at a distance D from the rear surface of the insert, and the outer groove point is positioned closer to the front surface of the insert than the rear surface.

[0030] In one embodiment, the distance D from the rear surface of the insert is 50% to 65% of the total distance between the rear and front surfaces of the insert.

[0031] In one embodiment, the top surface of the inner component includes an inner groove point, and the top surface of the outer component includes an outer groove point, wherein the outer groove point is positioned closer to the front surface of the insert than the inner groove point (e.g., the inner groove point is positioned closer to the rear surface of the insert than the outer groove point).

[0032] In one embodiment, the composite top surface of the side compartment includes a transition point defined as a transition point to the rear convex portion (e.g., a transition point between a flat section and a convex top section).

[0033] In one embodiment, the composite top surface of the side compartment includes a transition point defined as the front starting point of the convex top section (e.g., the transition point is located at the front end of the convex section).

[0034] In one embodiment, the transition point is located at a distance T from the rear surface of the insert, where T is approximately 40% to 50% of the total distance between the rear and front surfaces of the insert.

[0035] In one embodiment, the front surface of the side compartment includes a height of H. A The front lip and its height are H p The posterior lip, with a height of H A Greater than height H p .

[0036] In one embodiment, the insert is arranged and configured for use in a knee prosthesis during surgery in which the patient's posterior cruciate ligament is preserved and during surgery in which the patient's posterior cruciate ligament is removed.

[0037] In an alternative embodiment, a knee prosthesis is disclosed. The knee prosthesis includes a femoral component, a tibial component, and an insert. The femoral component includes a medial condylar surface, a lateral condylar surface, and an articular surface. The tibial component includes a load-bearing component. The insert is positioned between the articular surface and the load-bearing component, and the insert includes an anterior surface, a posterior surface, a medial surface, a lateral surface, a medial component, and a lateral component. The medial component includes a top surface arranged and configured to contact the medial condylar surface, and the top surface of the medial component includes a medial groove point. The lateral component includes a top surface arranged and configured to contact the lateral condylar surface, and the top surface of the lateral component includes a lateral groove point. The medial groove point is positioned closer to the posterior surface of the insert than the lateral groove point.

[0038] The embodiments of this disclosure offer numerous advantages. For example, according to this disclosure, the joint insert provides surgeons choosing to perform cruciate ligament-preserving or cruciate ligament-replacement (CRL) TKA with the option to improve adaptation to the patient's needs and changing soft tissue conditions that can affect knee replacement function and long-term clinical success. According to one or more features of this disclosure, the insert provides a concave medial compartment or surface with a more posterior groove and an increased anterior lip, thereby providing improved stability for different grades of PCL defects compared to existing inserts with a midline groove and lateral convexity. Furthermore, this insert provides improved lateral posterior translation compared to existing designs with concave or flat lateral joints lacking lateral posterior convexity.

[0039] The following describes in detail, with reference to the accompanying drawings, at least some of the additional features and advantages of embodiments of the invention, as well as the structure and operation of various embodiments of the invention. Attached Figure Description

[0040] Specific embodiments of the disclosed apparatus will now be described by way of example with reference to the accompanying drawings, in which:

[0041] Figure 1This is a perspective view of an embodiment of a knee prosthesis;

[0042] Figure 2 It is based on one or more features of this disclosure that can be used for Figure 1 A front perspective view of an embodiment of the insert in the knee prosthesis shown;

[0043] Figure 3 yes Figure 2 Rear perspective view of the insert shown;

[0044] Figure 4 yes Figure 2 Front elevation view of the insert shown;

[0045] Figure 5 yes Figure 2 Rear elevation view of the insert shown;

[0046] Figure 6 yes Figure 2 The inner side view of the insert shown;

[0047] Figure 7 yes Figure 2 The outer side view of the insert shown;

[0048] Figure 8 yes Figure 2 Top view of the insert shown;

[0049] Figure 9 yes Figure 2 The cross-sectional view of the insert shown is along... Figure 8 The line IX-IX in the middle is cut through the inner joint surface of the insert (i.e., the cross-sectional view is cut along the designed contact path on the inner side measured from the centerline 24mm of the insert);

[0050] Figure 10 yes Figure 2 The cross-sectional view of the insert shown is along... Figure 8 The line XX in the diagram is cut through the outer joint surface of the insert (i.e., the cross-sectional view is cut along the designed contact path on the outside, measured from the centerline 24mm of the insert).

[0051] Figure 11 yes Figure 2 The schematic diagram of the insert shown illustrates the cross-sectional geometry cut through the outer joint surface of the insert compared to known existing inserts (existing insert 1 and existing insert 2);

[0052] Figure 12 yes Figure 2The schematic diagram of the insert shown illustrates the cross-sectional geometry taken from the inner joint surface of the insert compared to known existing inserts (e.g., existing insert 1 and existing insert 2); and

[0053] Figure 13-22 It shows that Figure 2 Various test data comparing the insert shown with known existing inserts (e.g., existing insert 1 and existing insert 2).

[0054] The accompanying drawings are not necessarily drawn to scale. The drawings are merely illustrative and not intended to depict specific parameters of this disclosure. The drawings are intended to depict exemplary embodiments of this disclosure and are therefore not to be considered as limiting the scope. In the drawings, the same reference numerals denote the same elements. Detailed Implementation

[0055] Various features of inserts arranged and configured for use in knee prostheses will now be described more fully below with reference to the accompanying drawings, in which one or more features of the inserts will be shown and described. It should be understood that the various features may be used independently or in combination with each other. It should be understood that the inserts and accompanying knee prostheses disclosed herein may be embodied in many different forms and should not be construed as limited to the embodiments described herein. Rather, these embodiments are provided so that this disclosure will convey to those skilled in the art certain features of the inserts and accompanying knee prostheses.

[0056] As will be described herein, according to one or more features of this disclosure, an insert arranged and configured for use in a knee prosthesis or implant (the terms are used interchangeably herein and are not intended to be limiting). In one embodiment, as will be appreciated by one of ordinary skill, the knee prosthesis includes a tibial implant, components, etc. (the terms are used interchangeably herein and are not intended to be limiting), and a femoral component. The tibial component typically includes a tibial tray or load-bearing component (the terms are used interchangeably herein and are not intended to be limiting) and a support member arranged and configured to engage with the bone of a patient, such as the patient's tibia. Similarly, the femoral component typically includes an articulation component and a support member arranged and configured to engage with the bone of a patient, such as the patient's femur. In use, the tibial tray is arranged and configured to receive the insert, while the articulation component of the femoral component is arranged and configured to move against the top surface of the insert (e.g., joint movement).

[0057] Reference Figure 1The knee prosthesis 100 includes a femoral component 120 and a tibial component 140. During use, as will be readily apparent to those skilled in the art, the femoral component 120 is coupled to the distal end of the patient's femur, while the tibial component 140 is coupled to the proximal end of the patient's tibia. In use, the femoral component 120 moves relative to the tibial component 140. To facilitate this movement, the knee prosthesis 100 includes an insert 150 positioned between the femoral component 120 and the tibial component 140.

[0058] Generally, the insert 150 is attached to the tibial component 140 by any suitable mechanism now known or developed in the future, such as a mechanical connection (e.g., a dovetail joint), adhesive, etc. During use, the insert 150 is arranged and configured such that the femoral component 120 is movable relative to the tibial component 140. For example, the insert 150 may allow the femoral component 120 to rotate relative to the tibial component 140. Additionally, the insert 150 may allow the femoral component 120 to translate anteriorly and posteriorly, as well as rotate internally and externally, relative to the tibial component 140. In use, the insert 150 may be arranged and configured to guide, control, constrain, etc., the movement of the femoral component 120 relative to the tibial component 140. That is, the top surface of the insert 150 provides a surface against which the articular condyle portion of the femoral component abuts for articulation, for example, movement in a movement substantially corresponding to the movement of the femur relative to the tibia.

[0059] That is, as shown in the figure, the femoral component 120 includes a medial condylar portion 122 having a medial condylar surface 124 and a lateral condylar portion 126 having a lateral condylar surface 128. The medial condylar surface 124 and the lateral condylar surface 128 may be circular, and in some embodiments, may be asymmetrical. Between the medial condylar surface 124 and the lateral condylar surface 128, the femoral component 120 defines a trochlear groove 130 on which a patella or patellar implant can slide during knee flexion. In use, the insert includes a top surface having a medial compartment and a lateral compartment, the medial condylar surface 124 of the femoral compartment 120 being arranged and configured to contact the top surface of the medial compartment, while the lateral condylar surface 128 of the femoral compartment 120 being arranged and configured to contact the top surface of the lateral compartment.

[0060] Reference Figure 2-10 According to one or more features of this disclosure, an improved insert 200 is shown that can be used in a knee prosthesis. In use, insert 200 can replace insert 150 for connection. Figure 1 The knee prosthesis 100 is shown and described. However, it should be understood that the insert 200 can be used in conjunction with other suitable knee prostheses now known or developed in the future. Therefore, it should be understood that the insert of this disclosure is not limited to any particular knee prosthesis.

[0061] Insert 200 can have any suitable shape now known or developed in the future. For example, insert 200 can have any shape whose dimensions are determined and configured to correspond to the shapes of the femoral and tibial components. As shown and described, insert 200 can be sized and configured as a full insert for use in total knee replacement or revision knee replacement surgery. In one embodiment, insert 200 can be manufactured as a single or integral component. Alternatively, it is conceivable that insert 200 can be made of multiple components and then joined together. For example, in one embodiment, insert 200 can include an outer component and an inner component that separately represent a medial compartment and a lateral compartment, which are joined together by any suitable mechanism or method now known or developed in the future, such as by adhesives, mechanical connections, mechanical fasteners, etc.

[0062] Additionally, the insert 200 may include a notch formed in its posterior surface. In one embodiment, the insert 200 may be sized and shaped to match the outer contour of the femoral and / or tibial components, but this is not required. Alternatively and additionally, the insert may be arranged and configured to engage with the tibial and / or femoral components via any suitable mechanism now known or later developed. The insert may be made of any suitable material now known or later developed.

[0063] As shown in the figure, in one embodiment, the insert 200 can be arranged and configured for use in a left knee prosthesis. However, as those skilled in the art will appreciate, the insert 200 can be arranged and configured for use in a right knee prosthesis, the insert for the right knee prosthesis being a mirror image of the insert for the left knee prosthesis. In either case, the insert 200 includes a front surface 210, a rear surface 220, an inner surface 230, an outer surface 240, a top surface 250, and a bottom surface 252.

[0064] In one embodiment, the bottom surface 252 of the insert 200 is arranged and configured to engage with a tibial component, such as tibial component 140. In one embodiment, the insert 200 may be engaged with the tibial component by a mechanical connection (e.g., dovetail joint, interlocking protrusions and recesses, etc.), but other suitable connection mechanisms may also be used.

[0065] As shown in the figure, the top surface 250 of the insert 200 includes a medial compartment 260 and a lateral compartment 270. In use, the medial compartment 260 is arranged and configured to interact with the medial condylar surface 124 of the femoral component 120, and the lateral compartment 270 is arranged and configured to interact with the lateral condylar surface 128 of the femoral component 120. According to one or more features of this disclosure, the medial compartment 260 includes a generally concave dome surface 262 for contacting the medial condylar surface 124 of the femoral component 120 of the knee prosthesis, while the lateral compartment 270 includes at least a portion of a convex dome surface 272 of the lateral condylar surface 128 of the femoral component 120 of the knee prosthesis. This arrangement, by providing a generally concave top surface 262 in the inner compartment 260 of the insert 200, positions the inner groove of the joint insert 200 more rearward toward the rear surface 220 of the insert 200 compared to existing inserts that include a convex outer joint surface (e.g., see reference). Figure 9 As will be described in more detail herein, the inner groove coincides with the lowest point on the concave top surface 262 and is located at a distance D from the rear surface 220 of the insert 200. Additionally and / or alternatively, by providing a generally concave top surface 262 in the inner compartment 260 of the insert 200, the front lip 265 of the insert 200 can be increased (e.g., the height of the front lip 265 of the insert 200 in the inner compartment 260 of the insert 200 is increased compared to existing inserts). This arrangement, by providing an increased front lip 265 with a fully concave top surface 262, enables the inner compartment 260 to provide sufficient inner restraint for PCL defects and sacrificial conditions.

[0066] Reference Figure 10 The lateral compartment 270 can be arranged and configured to include an anterior concave portion with a relaxed anterior lip to enable spiral return during extension. As shown, the lateral anterior concave portion transitions into a reverse profile convex portion with an increased slope along the posterior half of the articular surface to facilitate lateral posterior translation, while also contributing to external rotation of the femur relative to the tibia as the knee moves to deeper flexion.

[0067] like Figure 9 As best shown in the figure, this figure illustrates a cross-sectional view of the insert 200 passing through the inner compartment 260, the cross-section being taken at a distance of approximately 24 mm from the midpoint of the insert 200. The inner compartment 260 includes a generally concave dome surface 262 extending from its rear surface 220 to its front surface 210. According to one or more features of this disclosure, it may also be referred to as the groove point P. m The bottom or lowest point P of the concave top surface 262 can be located at a distance D from the rear surface 220 of the insert 200. Therefore, according to one or more features of this disclosure, compared to existing inserts that include a convex lateral articulated surface without requiring further forward extension of the insert, the groove point P of the concave top surface 262... mPositioned closer to the rear surface 220 of the insert 200.

[0068] In one exemplary embodiment, the groove point P of the concave top surface 262 m The insertion can be positioned at a distance D from the posterior surface 220 of the insert 200, wherein the distance D is approximately equal to 25% to 50%, preferably 30% to 45%, and more preferably 35% to 40% of the total width (e.g., anterior / posterior dimension) of the insert 200. In one embodiment, the distance D may be approximately 35% to 37% of the total width (e.g., anterior / posterior dimension) of the insert 200. In an exemplary embodiment, the radius of curvature R of the concave dome surface 262 of the medial compartment 260 may range between 102% and 125% of the contact portion of the medial femoral condyle for use with compatible femoral components. As will be appreciated by those skilled in the art, the radius of curvature may vary depending on the size (e.g., width) of the insert.

[0069] Additionally, by using the groove point P on the concave top surface 262 m Arranged closer to the rear surface 220 than the front surface 210, the insert 200 is arranged and configured to provide an increased height H at the front lip 265. A In one exemplary embodiment, the groove point P, measured from the concave top surface 262, is located at a cross-section representing the approximate edge of the femoral contact area (e.g., a cross-section at the approximate midline (or closest to the midline) edge of the femoral contact area on the insert, approximately 13.5 mm from the midline of the insert) and relative to the corresponding groove of the receiving femoral condyle. m The height H at the tip of the anterior lip 265, measured to the tip of the anterior lip 265. A It can be 6.5mm to 10mm. In contrast, the insert 200 can include a smaller height H at the rear lip 267. p (For example, the height of the lip at the posterior lip 267 is less than the height of the lip at the anterior lip 265). In an exemplary embodiment, from the groove point P of the concave top surface 262... m The height H at the tip of the posterior lip 267 is measured. p It can be 3mm to 4mm. As those skilled in the art will appreciate, the height H at 265° of the front lip... A The height H at 267 on the posterior lip p It can vary depending on the size of the insert (e.g., A / P width).

[0070] As will be described and illustrated in more detail below, by including a ditch with a more rearward ditch (e.g., ditch point P). m (For example, the bottom or lowest point of the concave dome surface 262) is positioned closer to the inner compartment of the concave dome surface of the rear surface 220 and is increased in height H by including the front lip. AThe insert 200 is arranged and configured to provide improved stability for different grades of PCL defects compared to existing inserts on the market with a midline groove and a lateral protrusion. The insert 200 is thus arranged and configured for use in knee prostheses in patients experiencing PCL dysfunction or PCL resection.

[0071] In contrast, as previously described, the outer compartment 270 includes at least a portion of a convex or curved surface. That is, for example, as... Figure 10 As best shown in the figure, this diagram illustrates a cross-sectional view of the insert 200 passing through the outer compartment 270, the cross-section being taken at a distance of approximately 24 mm from the midpoint of the insert 200. The outer compartment 270 includes a composite top surface 272 extending from its rear surface 220 to its front surface 210 (e.g., the top surface 272 of the outer compartment 270 includes a composite curved surface), wherein at least a portion of the top surface 272 has a convex or curved surface. In one embodiment, the composite top surface 272 of the outer compartment 270 may include a first rear segment 272a, a second rear intermediate segment 272b, a third intermediate segment 272c, an optional fourth front intermediate segment 272d, and a fifth front segment 272e adjacent to the rear lip 276; however, this is only one configuration and the composite top surface 272 may include more or fewer segments.

[0072] In one embodiment, the first rear section 272a may form a rear (e.g., concave) curved surface that begins to form a lipped region at the rear lip 276. In use, the size of the first rear section 272a increases with the size of the insert. The second rear intermediate section 272b and the fifth front section 272e may each include a concave or curved surface, while the third intermediate section 272c includes a convex or curved surface. An optional fourth front intermediate section 272d may include a flat surface or section located between the third intermediate section 272c and the fifth front section 272e. In use, the flat surface or section 272d extends a short distance rearward from the fifth front section 272e before transitioning to the third intermediate section 272c. In one embodiment, the second rear intermediate segment 272b may have a different radius of curvature compared to the first rear segment 272a. This can affect the position of the transition point between the first rear segment 272a and the second rear intermediate segment 272b, thereby enabling the alteration of the slope between the second rear intermediate segment 272b and the third intermediate segment and / or increasing or decreasing the height H at the rear lip 276 in the outer compartment 270. p .

[0073] In one embodiment, according to one or more features of this disclosure, the groove point P of the composite top surface 272 of the outer compartment 270 L It appears at the transition point between the fifth front segment 272e and the optional fourth front intermediate segment 272d (e.g., groove point P). LLocated at the point where the fifth front section 272e meets the adjacent fourth front intermediate section 272d. That is, at the groove point P of the composite top surface 272 of the outer compartment 270. L Located at the rear end of the concave radius surface (e.g., the front segment 272e). Groove point P L It can be positioned at a distance D from the rear surface 220 of the insert 200. Therefore, according to one or more features of this disclosure, the groove point P of the composite top surface 272 of the outer compartment 270... L It can be positioned closer to the front surface 210 of the insert 200 than the rear surface 220. In an exemplary embodiment, the groove point P of the composite top surface 272 L It can be positioned at a distance D from the rear surface 220 of the insert 200, wherein the distance D is approximately 40% to 75%, preferably 50% to 65%, of the total width (e.g., front / rear dimension) of the insert 200.

[0074] In this arrangement, according to one or more features of this disclosure, the groove point P of the outer compartment 270 L It can be located as the groove point P, which is 260 degrees higher than the inner compartment. m Closer to the front surface 210 of the insert 200 (e.g., the groove point P of the inner compartment 260) m Position the trench point P, which is 270 degrees higher than the outer compartment. L (Closer to the rear surface of the insert). For example, in one embodiment, the groove point P of the outer compartment 270 L It can be located as the groove point P, which is 260 degrees higher than the inner compartment. m It is approximately 10% to 35% of the total distance between the front and rear surfaces and the front surface.

[0075] In one exemplary embodiment, the transition point T of the composite top surface 272 of the outer compartment 270 occurs at the transition point to the rear convex portion (e.g., the transition point between the optional fourth front intermediate section 272d and the third intermediate section 272c (e.g., the transition point T is located at the point where the fourth front intermediate section 272d meets the adjacent third intermediate section 272c)). Thus, the transition point T is defined as the front starting point of the convex radius of the third intermediate section 272c (e.g., at the rear end of the fourth front intermediate section 272d), while the groove point P... L It is confined to the front end of the fourth pre-intermediate segment 272d. In use, in one embodiment, due to the trench point P... L The transition point T can be connected by a flat surface (e.g., an optional fourth front intermediate section 272d), so they can be positioned at the same height from the bottom surface of the insert. However, alternatively, if the composite top surface 272 of the outer compartment 270 does not have an optional fourth front intermediate section 272d, then the groove point P... LThe transition point T can also coincide with the width of A / P. As shown in the figure, in one embodiment, the transition point T can be located at a distance T from the rear surface 220 of the insert 200, wherein the distance T is approximately 30% to 60%, preferably 35% to 55%, and more preferably 40% to 50% of the total width of the insert (e.g., front / rear dimension).

[0076] As used in this paper, by individually defining the groove point P L And the transition point T, can realize alternative embodiments of the top surface 272 including a flat portion, a transition to another concave rounded portion on the flat portion or convex surface, or a transition to the convex radius without any intermediate portion.

[0077] In this arrangement, the insert 200 is positioned and configured to provide a height H at the front lip 275 in the outer compartment 270. A In one exemplary embodiment, the measurement, taken at a cross-section representing the approximate edge of the femoral contact area (e.g., a cross-section at the approximate midpoint (or closest to the midline) edge of the femoral contact area on the insert, approximately 13.5 mm from the midline) and relative to the corresponding groove of the received femoral condyle, is from groove point P. L The height H of the anterior lip 275 in the outer compartment 270, measured to the tip of the anterior lip 275. A The diameter can be from 2.5 mm to 4.5 mm. In contrast, the insert 200 may include a height H at the rear lip 276 in the outer compartment 270. p In one exemplary embodiment, the height H at the posterior lip 276 is... p It can be from 0.5mm to 1.5mm. As those skilled in the art will appreciate, the height H at 276mm of the posterior lip... p This can vary depending on the size of the insert (e.g., A / P width). For example, the depth or height at the rear lip 276 is at the groove point P with the minimum insert size. L The maximum depth is approximately 1.5 mm below the insertion point. In use, as the insert size increases, the rear lip becomes more prominent, thus rising slightly higher due to the additional first rear section 272a. For the largest insert size, the depth (or the height of the rear lip) is at groove point P. L Approximately 0.5mm below.

[0078] In one exemplary embodiment, the foremost section or portion of the recessed dome surface 272 of the outer compartment 270 (e.g., the fifth foremost section 272e) Figure 10The radius of curvature R of the insert ranges from 155% to 225% of the radius of the contact portion of the lateral femoral condyle for use with compatible femoral components. In use, the lateral radius of curvature is arranged and configured to facilitate movement (e.g., spiral return during extension) because the lateral compartment is more relaxed, contrasting with the radius of curvature of the medial compartment, which is arranged and configured to restrict movement. As will be appreciated by those skilled in the art, the radius of curvature can vary depending on the size of the insert (e.g., width).

[0079] According to one or more features of this disclosure, an improved insert 200 for use in a knee prosthesis (e.g., knee prosthesis 100) is provided. For example, an articular insert 200 is provided by comprising a medial compartment 260 having a concave top surface 262 and a lateral compartment 270 having a composite top surface 272 including at least a portion of a convex surface, which is arranged and configured to facilitate the performance of cruciate ligament-preserving or cruciate ligament-replacement TKA surgery, with options for better adaptation to the patient's needs and varying soft tissue conditions that can affect knee replacement function and long-term clinical success.

[0080] According to one or more features of this disclosure, by including an inner compartment 260 with a concave top surface 262 having a rearward groove and an increased front lip, insert 200 provides improved stability for different grades of PCL defects (e.g., ...) compared to existing inserts on the market with a centerline groove and lateral protrusions. Figure 13 , 14 (As confirmed in 18 and 19). Conversely, according to one or more features of this disclosure, by including an inner compartment 260 having a concave top surface 262 and an outer compartment 270 having at least a partial protrusion, the insert 200 is arranged and configured to facilitate improved lateral rear translation compared to existing inserts on the market with concave or flat lateral joints. Figure 15 , 16 17, 20, 21 and 22).

[0081] Furthermore, in use, the insert 200 is arranged and configured for implantation during procedures that preserve the patient's PCL. (See reference...) Figure 13-17 Insert 200 is used to retain the patient's PCL within the knee prosthesis. For example... Figure 13-17 The data confirms that insert 200 performs similarly to the existing insert 1. During use, insert 200 maintains flexion and allows for a considerable amount of medial translation while preserving the patient's PCL (e.g., ...). Figure 13 and 14 (as provided in the middle), outer translation (such as) Figure 15 and 16 (as provided in) and internal / external rotation (such as) Figure 17 (As provided in the text). Posterior femoral rollback (e.g., translation) ( Figure 15 and 16 ) and internal / external rotation ( Figure 17 This design is an improvement over the more constrained design (existing insert 2), which also provides additional A / P constraints in cases where the PCL is preserved and the ligament integrity is not initially pristine or becomes increasingly defective after surgery.

[0082] on the contrary, Figure 18-22 This indicates that insert 200 can also be used in procedures that sacrifice the patient's PCL. (See reference...) Figure 18-22 Insert 200 is used within the knee prosthesis that sacrifices the patient's PCL. For example... Figure 18-22 The data confirms that insert 200 performs similarly to the existing insert 2, but with some improvements. Translation within the medial compartment is similar to a more constrained design (existing insert 2), which has the advantage of the femoral retention point being more anterior during extension (e.g., Figure 18 and 19 (As provided in the figure). Furthermore, these figures demonstrate improved stability relative to the standard CR insert design for conditions involving sacrificed PCL or severe PCL defects. Laterally, insert 200 promotes improved posterior translation of the femur in deeper flexion (as shown in the figure). Figure 20 and 21 (as provided in) and internal / external rotation (such as) Figure 22 (As provided in the text).

[0083] Reference Figure 13-22 Test data comparing an insert 200 according to one or more features of this disclosure (e.g., insert 200 comprising an inner compartment 260 having a concave top surface 262 and an outer compartment 270 having at least a partial protrusion, the concave top surface having a rearward groove and an increased anterior lip) with existing inserts and / or normal knees on the market is shown. As illustrated, insert 200 is compared with existing inserts (insert 1) comprising an inner compartment having a concave top surface including a midline groove and an outer protrusion, and existing inserts (insert 2) comprising concave top surfaces in both the inner and outer compartments.

[0084] Reference Figure 13 The figure illustrates tibiofemoral kinematics, which describes the forward / backward translation of the inner compartment of insert 200 when used in PCL retention state, compared to existing insert 1 and existing insert 2.

[0085] Reference Figure 14This figure illustrates the translation of the medial femoral condyle relative to the tibia during knee flexion between 60 and 120 degrees with insert 200, compared to existing inserts 1 and 2, and compared to a normal knee, when used with the PCL retained. The values ​​in parentheses describe the position of the lowest point of the medial condyle relative to the midline of the tibia in full extension.

[0086] Reference Figure 15 The figure illustrates tibiofemoral kinematics, which describes the forward / backward translation of the outer compartment of insert 200 when used in PCL retention mode, compared to existing inserts 1 and 2 in the market.

[0087] Reference Figure 16 This figure illustrates the translation of the lateral femoral condyle relative to the tibia during knee flexion between 60 and 120 degrees at insert 200, compared to existing inserts 1 and 2, and compared to a normal knee, when used with the PCL retained. The values ​​in parentheses describe the position of the lowest point of the lateral condyle relative to the midline of the tibia at full extension.

[0088] Reference Figure 17 The figure illustrates tibiofemoral kinematics, which describes the internal / external rotation of insert 200 when used in PCL-retained state, compared to existing insert 1 and existing insert 2.

[0089] Reference Figure 18 The figure illustrates tibiofemoral kinematics, which describes the forward / backward translation within the inner compartment of insert 200 when used in PCL sacrificial state, compared to existing insert 1 and existing insert 2.

[0090] Reference Figure 19 This figure illustrates the translation of the medial femoral condyle relative to the tibia during knee flexion between 60 and 120 degrees in insert 200, compared to existing inserts 1 and 2, when used in PCL sacrificial configuration. The values ​​in parentheses describe the position of the medial condyle's lowest point relative to the midline of the tibia in full extension.

[0091] Reference Figure 20 The figure illustrates tibiofemoral kinematics, which describes the forward / backward translation of the outer compartment of insert 200 when used in PCL sacrificial state, compared to existing insert 1 and existing insert 2.

[0092] Reference Figure 21 This figure illustrates the translation of the lateral femoral condyle relative to the tibia during knee flexion between 60 and 120 degrees in insert 200, compared to existing inserts 1 and 2, when used in PCL sacrificial configuration. The values ​​in parentheses describe the position of the lowest point of the lateral condyle relative to the midline of the tibia in full extension.

[0093] Reference Figure 22 The figure illustrates tibiofemoral kinematics, which describes the internal / external rotation of insert 200 when used in PCL sacrificial state, compared to existing insert 1 and existing insert 2.

[0094] In use, as previously described, insert 200 can be used in conjunction with any suitable knee prosthesis (e.g., femoral and tibial components) now known or developed in the future. Furthermore, insert 200 can be made from any suitable biocompatible material now known or developed in the future for manufacturing orthopedic inserts, including, for example, plastic or polymeric materials such as ultra-high molecular weight polyethylene. Additionally, insert 200 can be constructed in any suitable manner now known or developed in the future. For example, insert 200 can be machined, molded, or otherwise constructed in various sizes as a single monolithic unit from medical-grade physiologically acceptable plastics (e.g., ultra-high molecular weight polyethylene, etc.) to fit a range of typical patients, or it can be custom-designed for a specific patient based on data provided by a surgeon after physical and radiographic examinations. Materials can be treated, for example, by radiation, chemicals, or other techniques to alter their wear characteristics and / or strength or hardness. Various portions of the various surfaces of the insert can be treated with radiation, chemicals, or other substances or techniques to enhance wear resistance; they can also undergo suitable surface treatments for such and other purposes.

[0095] In use, the insert 200 can be supplied separately, as part of a knee prosthesis, or as part of a kit that includes inserts of various sizes, tibial components, and / or femoral components. Alternatively, a patient-matched knee prosthesis may be configured with certain geometries and / or other features of the implant tailored to the specific anatomy of a particular patient.

[0096] This document uses terms such as top, bottom, above, below, inside, outside, front, back, proximal, and distal. However, such terms are not limited to specific coordinate orientations, distances, or dimensions, but are used to describe relative positions with reference to specific embodiments. Such terms are generally not limited to the scope of the claims set forth herein. Any embodiment or feature of any section, portion, or any other component shown or specifically described with respect to various embodiments of similar sections, portions, or components herein may be interchangeably applied to any other similar embodiments or features shown or described herein.

[0097] While this disclosure refers to certain embodiments, many modifications, alterations, and variations of the described embodiments are possible without departing from the field and scope of this disclosure as defined in the appended claims. Therefore, this disclosure is not intended to be limited to the described embodiments. Rather, these embodiments should be considered illustrative rather than restrictive. All changes and modifications falling within the spirit of the invention will be considered to be within the scope of this disclosure. This disclosure should be given the full scope defined by the language of the appended claims and their equivalents.

[0098] The above description has broad applications. The discussion of any embodiment is intended to be illustrative only and is not intended to imply that the scope of this disclosure (including the claims) is limited to these embodiments. In other words, while illustrative embodiments of this disclosure have been described in detail herein, it should be understood that the inventive concept can be implemented and employed in other different ways, and the appended claims are intended to be construed as including such variations, in addition to being limited by the prior art.

[0099] It should be understood that, as described herein, an “embodiment” (as illustrated in the accompanying drawings) may refer to an illustrative representation of an environment or article of manufacture or component that provides or implements the disclosed concept or feature, or a representation of a manner in which only the concept or feature is provided or implemented. However, such illustrated embodiments are to be understood as examples (unless otherwise stated), and other ways of embodying the described concepts or features, such as those that a person of ordinary skill in the art would understand upon learning the concepts or features from this disclosure, are all within the scope of this disclosure. Furthermore, it should be appreciated that although the drawings may show one or more embodiments of a concept or feature together in a single embodiment of an environment, article of manufacture, or component incorporating such a concept or feature, it should be understood that such concepts or features (unless otherwise specified) are independent and separate from each other, shown together for convenience, but not intended to limit their co-existence or use. For example, a feature illustrated or described as part of an embodiment may be used alone or together with another embodiment to produce yet another embodiment. Therefore, this subject matter is intended to cover such modifications and variations that fall within the scope of the appended claims and their equivalents.

[0100] As used herein, an element or step described in the singular and preceded by the word "a / an" should be understood to not exclude a plurality of elements or steps, unless such exclusion is explicitly stated.

[0101] As used herein, the phrases “at least one,” “one or more,” and “and / or” are open-ended expressions for combining and separating in operation. The terms “a” (or “an”), “one or more,” and “at least one” are used interchangeably herein. Unless otherwise stated, connection references (e.g., engagement, attachment, linking, joining, and joining) should be interpreted broadly and may include intermediate members between sets of elements as well as intermediate members that move relative to the elements. Thus, a connection reference does not necessarily infer that two elements are directly connected and have a fixed relationship with each other. Identifying references (e.g., first, second, first, third, fourth, etc.) are not intended to imply importance or priority but are used to distinguish one feature from another. The figures are for illustrative purposes only, and the dimensions, positions, order, and relative sizes reflected in the figures accompanying this document may vary.

[0102] The foregoing discussion has been presented for purposes of illustration and description and is not intended to limit this disclosure to one or more of the forms disclosed herein. For example, for the purpose of simplifying this disclosure, various features of this disclosure have been grouped together in one or more embodiments or constructions. However, it should be understood that various features of certain embodiments or constructions of this disclosure may be combined in alternative embodiments or constructions. Furthermore, the following claims are hereby incorporated into this detailed description by reference, wherein each claim is an independent embodiment of this disclosure.

Claims

1. A knee prosthesis, comprising: A femoral component, the femoral component including a medial condylar surface, a lateral condylar surface, and an articular surface; Tibial component, the tibial component including a load-bearing component; as well as An insert located between the joint surface and the load-bearing component, the insert comprising a front surface, a rear surface, an inner surface, an outer surface, an inner component, and an outer component, wherein: The inner component includes a top surface arranged and configured to contact the inner condyle surface, the top surface of the inner component including an inner groove; and The outer component includes a top surface arranged and configured to contact the outer condyle surface, the top surface of the outer component including an outer groove point; in: The inner groove point is positioned closer to the rear surface than the front surface; and The inner groove point is positioned closer to the rear surface of the insert than the outer groove point.

2. The knee prosthesis of claim 1, wherein the lateral groove point is positioned closer to the anterior surface than the posterior surface.

3. The knee prosthesis according to claim 1 or 2, wherein the lateral groove point is positioned anterior to the medial groove point by 10% to 35% of the total distance between the posterior and anterior surfaces.

4. The knee prosthesis according to claim 1 or 2, wherein the lateral groove point is located at a distance D from the posterior surface, wherein the distance D is 50% to 65% of the total distance between the posterior surface and the anterior surface.

5. The knee prosthesis according to claim 1 or 2, wherein the medial groove point is located at a distance D from the posterior surface, wherein the distance D is 30% to 45% of the total distance between the posterior surface and the anterior surface.

6. The knee prosthesis according to claim 1 or 2, wherein the medial groove point is located at a distance D from the posterior surface, wherein the distance D is 35% to 40% of the total distance between the posterior surface and the anterior surface.

7. The knee prosthesis according to claim 1 or 2, wherein the top surface of the inner component includes a concave surface, and the top surface of the outer component includes a composite surface, the composite surface having at least a convex segment including a convex surface.

8. The knee prosthesis of claim 7, wherein the concave surface of the medial component extends completely from the posterior surface to the anterior surface.

9. The knee prosthesis of claim 7, wherein the medial component comprises an anterior lip and a posterior lip, the anterior lip having a height H measured from the medial groove point to the tip of the anterior lip. A The posterior lip has a height H measured from the inner groove point to the tip of the posterior lip. p The height H A Greater than height H p .

10. The knee prosthesis according to claim 9, wherein the height H at the anterior lip is... A Between 6.5mm and 10mm, and the height H at the rear lip. p Between 3mm and 4mm.

11. The knee prosthesis of claim 7, wherein the composite surface of the top surface of the lateral compartment includes an anterior segment with a concave surface.

12. The knee prosthesis of claim 11, wherein the composite surface of the top surface of the outer component includes a concave rear section located between the rear surface and the convex section.

13. The knee prosthesis of claim 12, wherein the composite surface of the top surface of the outer component includes a rear concave intermediate section located between the concave rear section and the convex section.

14. The knee prosthesis of claim 12, wherein the composite surface of the top surface of the outer component includes a flat section located between the concave section and the convex section.

15. The knee prosthesis of claim 14, wherein the lateral groove point is located at the transition between the concave section and the flat section.

16. The knee prosthesis of claim 7, wherein the composite surface of the top surface of the outer component includes a transition point defined at the front end of the convex segment, the transition point being located at a distance T from the rear surface, wherein the distance T is 40% to 50% of the total distance between the rear surface and the front surface.

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