Inserts for use in knee prostheses

Abstract

The present invention provides a joint insert for a CR-type knee prosthesis that enables reliable movement promoting improved knee function while providing favorable A / P constraints with respect to the state of the remaining innate soft tissue structure. [Solution] In one embodiment, the insert comprises an inner portion (260) and an outer portion (270). The inner portion comprises an upper surface (262) having a concave or curved surface with a more posterior groove (Pm) and an enlarged anterior lip portion (265). The outer portion comprises an upper surface (272) having a convex surface or curved surface in at least one area or portion. With this arrangement, the insert is positioned and configured to provide improved stability for various grades of PCL defects compared to existing inserts having a median groove and an lateral convexity. In addition, the insert provides improved posterior lateral translation compared to existing designs with concave or flat lateral articulation lacking a posterior lateral convexity.

Description

[Technical Field] 【0001】 Cross-reference of related applications This application is a non-provisional application of the pending U.S. Provisional Patent Application No. 63 / 082,759, filed September 24, 2020, entitled "Insert for Use in a Knee Prosthesis," which is incorporated herein by reference in its entirety. 【0002】 This disclosure relates to orthopedic implants, more specifically, inserts for use in orthopedic knee prostheses. [Background technology] 【0003】 Knee arthroplasty or knee replacement generally involves the implantation, placement, etc. (as used herein interchangeably without intent to limit) of orthopedic implants, such as knee prostheses, into the patient's knee. For example, in connection with total knee arthroplasty or knee replacement ("TKA"), the orthopedic implant (e.g., knee prosthesis) may include femoral and tibial components. When in use, the femoral component is attached to the patient's femur, and the tibial component is attached to the patient's tibia. Generally, the femoral and tibial components may each include support members, such as intramedullary stems that can be attached to, for example, joint components, trays, load-bearing components (as used herein interchangeably without intent to limit). When in use, the support members are positioned and configured to connect to the patient's bone and may be inserted into the intramedullary canal of the patient's bone, for example, while a tray is mounted on a prepared surface on the patient's bone. Bearing members or inserts are typically mounted on the tray of the tibial component. 【0004】 Total knee arthroplasty (TKA) may be performed to address damage in multiple compartments of a patient's knee joint, for example, due to arthritis. The TKA procedure aims to alleviate chronic intra-articular pain and restore function to the affected knee. Early knee prostheses tended to largely disregard the patient's natural ligamentary structure, while primarily focusing on stabilizing the knee through guided movement. However, with advances in arthroplasty and improvements in implant fixation, new designs have emerged that work in conjunction with the patient's soft tissue structure, providing varying degrees of stability based on the patient's specific needs and the surgeon's preference, while allowing for increased freedom of movement of the patient's femur relative to the patient's tibia. 【0005】 Today, knee prostheses can be divided into four main classifications based on how the cruciate ligaments are managed. Posterior stable ("PS") designs replace the posterior cruciate ligament ("PCL") with a cam-post mechanism that helps control anterior translation during knee flexion, while compensating for both cruciate ligaments in the patient's knee. Cruciate ligament compensatory ("CS") and deep-dish ("DD") designs also allow for the removal of both cruciate ligaments while providing a more conscientious joint shape that helps stabilize the joint. Posterior cruciate ligament preservation ("CR") designs compensate for only the anterior cruciate ligament while preserving the PCL. This is intended to provide anterior / posterior (A / P) stability to the femur as this structure flexes relative to the tibia, while the less conscientious joint shape allows for increased autonomic movement. The fourth type of TKA is the bicruciate ligament-preserving ("BCR") design, which preserves both cruciate ligaments and offers limited fit and morphological constraints, relying solely on soft tissue structures to drive knee kinematics. While BCR knee prostheses may offer theoretical advantages for enabling more normal kinematics, their use remains quite limited because many surgeons have not mastered the more advanced surgical techniques required to perform such surgeries. As a result, the majority of TKA procedures performed today continue to use either PS or CR knee prosthesis designs. 【0006】 While PS-type designs tend to promote more reliable kinematics compared to most CR-type designs, the box shape of the femoral component in PS-type designs eliminates the need for resection, leading to a growing trend towards preserving the patient's natural bone. Therefore, more surgeons are seeking implants like CR-type and CS-type designs that allow for bone preservation while still providing appropriate A / P constraints with reliable kinematics. Additionally, surgeons who frequently perform TKA with CR-type implants may encounter cases where the preserved PCL does not provide acceptable A / P constraints when using many of the more standard joint CR inserts. This can become apparent intraoperatively if the PCL turns out to be non-original, or it can occur postoperatively as the PCL begins to loosen within the joint, giving laxity. On the other hand, the option of using CS and DD inserts is less desirable unless the patient requires additional constraints, as the more constrictive joint shape may hinder condylar movement that promotes kinematics for improving knee flexion. 【0007】 Currently, there is an increasing use of CR and CS / DD type knee prostheses by surgeons who typically perform TKA procedures using PS implants. This shift in surgical perspectives is supported by the number of CR / CS and DD type knee prostheses currently available on the market that meet the needs of bone preservation while also providing increased stability even when both cruciate ligaments are resected. These implant systems facilitate the use of specialized joint inserts with various joint conformities and characteristics. One existing design is the medial swivel knee, which utilizes a trough within the medial part of the joint insert that tightly conforms to the shape of the medial femoral condyle. This shape helps prevent anterior sliding of the femur over the tibia. Other existing designs implement concave or cup-shaped features within both the medial and lateral compartments of the joint insert. These options are also more conformable and tend to promote increased A / P stability by matching both the medial and lateral femoral condyles at a defined flexion angle. 【0008】 Nevertheless, it would be beneficial to provide an articular insert for a CR type knee prosthesis that enables reliable movement that promotes improvement of knee function while providing suitable A / P constraints with respect to the state of the remaining native soft tissue structures. 【0009】 With this in mind, the present disclosure is provided. 【0010】 Summary This summary is provided to introduce a series of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter. 【0011】 In one embodiment, an insert suitable for use in a knee prosthesis is disclosed. In one embodiment, the articular insert is arranged and configured to be used in connection with an existing knee prosthesis, such as an existing TKA CR femoral component, which, in combination with the soft tissue structures, promotes improved stability over existing CR insert designs while promoting improved knee rotation and flexion compared to existing CS / DD insert designs by promoting the kinematics within the lateral portion that helps to facilitate such improvement. 【0012】 In one embodiment, the insert includes a generally concave inner portion and a convex outer portion. That is, in one embodiment, the insert includes an inner portion for contacting the medial condyle formed on the femoral component or bone and an outer portion for contacting the lateral condyle on the femoral component or bone. The inner portion includes an upper surface having a generally concave surface or curve. The outer portion includes an upper surface having a complex curve with at least one region or portion including a generally convex surface or curve. 【0013】 With such an arrangement, during use, the inner groove of this joint insert is positioned substantially more posteriorly, thereby allowing an increase in the anterior lip having a fully concave shape that exactly matches the shape of the medial femoral condyle in the contact area for a femoral component of a matching size. As a result, the medial portion can provide sufficient medial constraint for both the PCL-deficient state and the compensatory state. In combination with the concave medial portion that provides further stability, the lateral portion is optimized to have a pre-recess with a relaxed anterior lip in order to allow a screw-home during extension. This lateral pre-recess transitions to a convex portion with a reverse profile where the slope increases along the posterior half of the articular surface, promoting lateral posterior translation while helping to impart external rotation of the femur relative to the tibia as the knee moves into deeper flexion. 【0014】 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 a front surface, a rear surface, a medial surface, a lateral surface, a top surface, a bottom surface, a medial portion, and a lateral portion. During use, the medial portion is arranged and configured to interact with the medial condylar surface of the femoral component. The lateral portion is arranged and configured to interact with the lateral condylar surface of the femoral component. In one embodiment, the medial portion includes a concave top surface for contacting the medial condylar surface of the femoral component, while the lateral portion includes a top surface including a compound curve having at least a convex upper section for contacting the lateral condylar surface of the femoral component. 【0015】 In one embodiment, the concave top surface of the medial portion includes a medial groove point, and the medial groove point is positioned closer to the rear surface than to the front surface. 【0016】 In one embodiment, the medial groove point is positioned at a distance D from the rear surface of the insert, and the distance D is about 35% - 40% of the total distance between the rear surface and the front surface of the insert. 【0017】 In one embodiment, the rear surface is an anterior lip having a height H measured from the medial groove point to the tip of the anterior lip 【0017】 and a posterior lip having a height H measured from the medial groove point to the tip of the posterior lip pIt includes a posterior lip portion having a height H A is, height H p It is larger than that. 【0018】 In one embodiment, the height H of the anterior lip A The size is 6.5mm to 10mm. 【0019】 In one embodiment, the height H of the posterior lip p It is 3mm to 4mm in size. 【0020】 In one embodiment, the concave upper surface extends completely from the rear surface to the front surface. 【0021】 In one embodiment, the outer portion of the double-centered upper surface includes a pre-recessed portion (e.g., a pre-recessed portion including a concave surface) that transitions to a convex portion (e.g., a convex portion) having an inverse contour. 【0022】 In one embodiment, the double-core upper surface includes a concave rear section positioned between the rear surface of the insert and the convex upper section. 【0023】 In one embodiment, the double-centered upper surface includes a concave intermediate section located between the concave rear section and the convex upper section. 【0024】 In one embodiment, the double-core upper surface includes a concave front section positioned between the front surface of the insert and the convex upper section. 【0025】 In one embodiment, the double-centered upper surface includes a flat section located between a concave front section and a convex upper section. 【0026】 In one embodiment, the double-centered upper surface of the outer portion includes an outer groove point defined as a transition zone between a concave front section and a flat section (for example, the outer groove point is located in the transition zone between the concave front section and the flat section). 【0027】 In one embodiment, the double-centered upper surface of the outer portion includes an outer groove point at the rearmost end of the concave front section (for example, the outer groove point is at the rear end of the concave front section). 【0028】 In one embodiment, the outer groove points are positioned at a distance D from the rear surface of the insert, and the outer groove points are positioned closer to the front surface of the insert than the rear surface. 【0029】 In one embodiment, the distance D from the rear surface of the insert is 50% to 65% of the total distance between the rear surface and the front surface of the insert. 【0030】 In one embodiment, the upper surface of the inner part includes inner groove points, the upper surface of the outer part includes outer groove points, and the outer groove points are positioned closer to the front surface of the insert than the inner groove points (for example, the inner groove points are positioned closer to the rear surface of the insert than the outer groove points). 【0031】 In one embodiment, the complex upper surface of the outer part includes a transition point defined as the point of transition to the posterior convexity (for example, the point of transition between the flat section and the convex upper section). 【0032】 In one embodiment, the complex upper surface of the outer part includes a transition point defined as the starting point in front of the convex upper section (for example, the transition point is at the front end of the convex section). 【0033】 In one embodiment, the transition point is positioned at a distance T from the rear surface of the insert, and the distance T is about 40% to 50% of the total distance between the rear surface and the front surface of the insert. 【0034】 In one embodiment, the front surface of the outer part has A a front lip having a height H p and a rear lip having a height H A where the height H p is higher than the height H. 【0035】 In one embodiment, the insert is arranged and configured to be used in a knee prosthesis in a surgical procedure in which the patient's posterior cruciate ligament is preserved and in a surgical procedure in which the patient's posterior cruciate ligament is resected. 【0036】 In an alternative embodiment, a knee prosthesis is disclosed. This 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 includes an anterior, posterior, medial, lateral surfaces, an internal component, and an external component. The internal component includes an upper surface configured to contact the medial condylar surface, and the upper surface of the internal component includes an internal groove point. The external component includes an upper surface configured to contact the lateral condylar surface, and the upper surface of the external component includes an external groove point. The internal groove point is located closer to the posterior surface of the insert than the external groove point. 【0037】 Embodiments of this disclosure offer numerous advantages. For example, according to this disclosure, the joint insert provides surgeons who choose to perform cruciate ligament-preserving or cruciate ligament replacement TKA procedures with an improved option for adapting to patient needs and various soft tissue conditions, which can affect knee replacement function and long-term clinical outcomes. According to one or more features of this disclosure, the insert provides a concave medial portion with a more posterior groove and an enlarged posterior lip, thereby improving stability for various grades of PCL defects compared to existing inserts with a median groove and lateral convexity. In addition, the insert provides improved posterolateral translation compared to existing designs with concave or flat lateral joints lacking a posterolateral convexity. 【0038】 Further features and advantages of at least some embodiments of the present invention, as well as the structure and operation of various embodiments of the present invention, will be described below in detail with reference to the accompanying drawings. [Brief explanation of the drawing] 【0039】 As an example, specific embodiments of the devices disclosed hereafter will be described with reference to the following accompanying drawings. [Figure 1] This is a perspective view of an embodiment of a knee prosthesis. [Figure 2]This is a front perspective view of an embodiment of an insert that may be used in a knee prosthesis shown in Figure 1, according to one or more features of the present disclosure. [Figure 3] Figure 2 is a rear perspective view of the insert shown. [Figure 4] Figure 2 is a front elevation view of the insert shown. [Figure 5] Figure 2 is a rear elevation view of the insert shown. [Figure 6] Figure 2 is an inside side view of the insert shown. [Figure 7] Figure 2 is an external side view of the insert shown. [Figure 8] Figure 2 is a top view of the insert shown. [Figure 9] Figure 2 is a cross-sectional view of the insert, taken from the medial articular surface of the insert along line IX-IX in Figure 8 (i.e., a cross-sectional view taken along the designed contact path located 24 mm inside from the midline of the insert). [Figure 10] Figure 2 is a cross-sectional view of the insert, taken from the lateral articular surface of the insert along line XX in Figure 8 (i.e., a cross-sectional view taken along the designed contact path located 24 mm inside from the midline of the insert). [Figure 11] Figure 2 is a schematic diagram of the insert, illustrating the cross-sectional shape of this insert taken from the lateral articular surface, compared to known existing inserts (existing insert 1 and existing insert 2). [Figure 12] Figure 2 is a schematic diagram of the insert, illustrating the cross-sectional shape of this insert taken from the inner articular surface, compared to known existing inserts (e.g., existing insert 1 and existing insert 2). [Figure 13] Figure 2 illustrates various test data comparing the insert shown with known existing inserts (e.g., existing insert 1 and existing insert 2). [Figure 14]Figure 2 illustrates various test data comparing the insert shown with known existing inserts (e.g., existing insert 1 and existing insert 2). [Figure 15] Figure 2 illustrates various test data comparing the insert shown with known existing inserts (e.g., existing insert 1 and existing insert 2). [Figure 16] Figure 2 illustrates various test data comparing the insert shown with known existing inserts (e.g., existing insert 1 and existing insert 2). [Figure 17] Figure 2 illustrates various test data comparing the insert shown with known existing inserts (e.g., existing insert 1 and existing insert 2). [Figure 18] Figure 2 illustrates various test data comparing the insert shown with known existing inserts (e.g., existing insert 1 and existing insert 2). [Figure 19] Figure 2 illustrates various test data comparing the insert shown with known existing inserts (e.g., existing insert 1 and existing insert 2). [Figure 20] Figure 2 illustrates various test data comparing the insert shown with known existing inserts (e.g., existing insert 1 and existing insert 2). [Figure 21] Figure 2 illustrates various test data comparing the insert shown with known existing inserts (e.g., existing insert 1 and existing insert 2). [Figure 22] Figure 2 illustrates various test data comparing the insert shown with known existing inserts (e.g., existing insert 1 and existing insert 2). 【0040】 The drawings are not necessarily to scale. The drawings are not intended to depict any specific parameter of the disclosure, but are merely representational. The drawings are intended to illustrate exemplary embodiments of the disclosure and are therefore not to be considered limitations of scope. In the drawings, similar numbers represent similar elements. [Modes for carrying out the invention] 【0041】 Hereafter, various features or similar characteristics of the insert, which is arranged and configured for use in a knee prosthesis, will be described more fully in the following text with reference to the accompanying drawings, and one or more features of the insert will be shown and described here. It will be understood that the various features may be used independently or in combination with each other. It will be understood that the insert and accompanying knee prostheses disclosed herein may be embodied in many different forms and should not be construed as being limited to the embodiments shown herein. Rather, these embodiments are provided so that the disclosure conveys certain features of the insert and accompanying knee prosthesis to those skilled in the art. 【0042】 As described herein, an insert is disclosed which is positioned and configured for use in a knee prosthesis or implant (as used herein interchangeably without intent to limit) according to one or more features of this disclosure. In one embodiment, as will be understood by those skilled in the art, the knee prosthesis includes a tibial implant, components, etc. (as used herein interchangeably without intent to limit) and a femoral component. The tibial component generally includes a tibial tray or load-bearing component (as used herein interchangeably without intent to limit) and a support member positioned and configured to bond to a patient bone, such as the patient's tibia. Similarly, the femoral component generally includes an articular component and a support member positioned and configured to bond to a patient bone, such as the patient's femur. When in use, the tibial tray is positioned and configured to receive the insert, while the articular component of the femoral component is positioned and configured to move (e.g., articularly) relative to the upper surface of the insert. 【0043】 Referring to Figure 1, the 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 connects to the distal end of the patient's femur, while the tibial component 140 connects to the proximal end of the patient's tibia. During 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. 【0044】 Generally speaking, the insert 150 is coupled to the tibial component 140 by any preferred mechanism currently known or to be developed in the future, such as a mechanical connection (e.g., dovetail joint), an adhesive, etc. During use, the insert 150 is positioned and configured to allow the femoral component 120 to move relative to the tibial component 140. For example, the insert 150 may allow rotation of the femoral component 120 relative to the tibial component 140. In addition, the insert 150 may allow anterior-posterior translation, as well as internal and external rotation of the femoral component 120 relative to the tibial component 140. During use, the insert 150 may be configured to guide, control, or restrict the movement of the femoral component 120 relative to the tibial component 140. That is, the upper surface of the insert 150 provides a surface to which the articulating condyle portion of the femoral component articulates, for example, moves, in a movement that generally corresponds to the movement of the femur relative to the tibia. 【0045】 In other words, 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 rounded and, in some implementations, 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 the patella or patellar implant can slide during knee flexion. When in use, the insert includes an upper surface having a medial portion and a lateral portion, with the medial condylar surface 124 of the femoral portion 120 positioned to contact the upper surface of the medial portion, while the lateral condylar surface 128 of the femoral portion 120 is positioned to contact the upper surface of the lateral portion. 【0046】 Referring to Figures 2-10, improved inserts 200 that may be used in knee prostheses according to one or more features of the present disclosure are illustrated. When used, insert 200 may be used in knee prostheses 100 shown and described in relation to Figure 1 in place of insert 150. However, it is understood that insert 200 may be used in relation to other suitable knee prostheses that are currently known or to be developed in the future. Therefore, it is understood that the inserts of the present disclosure are not limited to any particular knee prosthesis. 【0047】 The insert 200 may have any preferred shape that is currently known or may be developed in the future. For example, the insert 200 may have any shape that is sized and configured to correspond to the shapes of the femoral and tibial components. As shown and described, the insert 200 may be sized and configured as a complete insert that is sized and configured for use in total knee arthroplasty or revision knee arthroplasty. In one embodiment, the insert may be manufactured as a monolithic or single piece. Alternatively, the insert may be manufactured from multiple parts that are later joined together. For example, in one embodiment, the insert may include an outer part and an inner part, each representing an inner and outer part, which are joined together by any preferred mechanism or method that is currently known or may be developed, such as an adhesive, mechanical connection, or mechanical fastener. 【0048】 In addition, the insert 200 may have a notch formed on its rear surface. In one embodiment, the insert 200 may be sized and shaped to match the external shape of the femoral and / or tibial components, but this is not required. In addition, and / or, the insert may be positioned and configured to bond to the tibial and / or femoral components by any preferred mechanism currently known or to be developed in the future. The insert may be manufactured from any preferred material currently known or to be developed in the future. 【0049】 As shown in the illustration, in one embodiment, the insert 200 may be positioned and configured for use in a left knee prosthesis. However, as those skilled in the art will understand, the insert 200 may also be positioned and configured for use in a right knee prosthesis, and the insert for the right knee prosthesis is 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. 【0050】 In one embodiment, the bottom surface 252 of the insert 200 is positioned and configured to connect to a tibial component, such as a tibial component 140. In one embodiment, the insert 200 may be connected to the tibial component by mechanical connections such as dovetail joints, interlocking protrusions, and recesses, but other suitable connection mechanisms may be used. 【0051】 As shown in the figure, the upper surface 250 of the insert 200 includes an inner portion 260 and an outer portion 270. When in use, the inner portion 260 is configured to interact with the medial condylar surface 124 of the femoral component 120, and the outer portion 270 is configured to interact with the lateral condylar surface 128 of the femoral component 120. According to one or more features of the present disclosure, the inner portion 260 includes a substantially concave upper surface 262 for contacting the medial condylar surface 124 of the femoral component 120 of the knee prosthesis, while the outer portion 270 includes at least a portion of a convex upper surface 272 for contacting the lateral condylar surface 128 of the femoral component 120 of the knee prosthesis. This arrangement provides a substantially concave upper surface 262 within the inner portion 260 of the insert 200, thereby positioning the inner groove of the articular insert 200 further posterior to the rear surface 220 of the insert 200 compared to existing inserts that incorporate a convex outer articular surface (for example, as described in more detail herein, in Figure 9, the inner groove coincides with the lowest point on the concave upper surface 262 and is positioned at a distance D from the rear surface 220 of the insert 200). In addition and / or, providing a substantially concave upper surface 262 within the inner portion 260 of the insert 200 may increase the anterior lip portion 265 of the insert 200 (for example, the height of the anterior lip portion 265 of the insert 200 within the inner portion 260 of the insert 200 is increased compared to existing inserts). This arrangement allows the inner portion 260 to provide sufficient internal constraint for both PCL deficiency and compensatory states by providing the increased anterior lip portion 265 to the completely concave upper surface 262. 【0052】 Referring to Figure 10, the lateral portion 270 may be positioned and configured to incorporate an anterior recess having a relaxed anterior lip to allow screw-home during extension. As shown, this lateral anterior recess transitions into a convex portion with an inverted contour that increases in slope along the posterior half of the articular surface, promoting lateral posterior translation while simultaneously assisting in external rotation of the femur relative to the tibia as the knee moves into deeper flexion. 【0053】 As best illustrated in Figure 9, which shows a cross-sectional view of the insert 200 passing through the inner portion 260, taken at a distance of approximately 24 mm from the midpoint of the insert 200, the inner portion 260 includes a substantially concave upper surface 262 extending from the rear surface 220 to the front surface 210. According to one or more features of this disclosure, groove point P m The bottom or lowest point P of the concave upper surface 262, which may also be called the groove point, may 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, the groove point P of the concave upper surface 262 may be located at a distance D from the rear surface 220 of the insert 200. m Compared to existing inserts that incorporate a convex lateral articular surface without requiring the insert to extend further forward, this allows the insert to be positioned closer to the posterior surface 220 of the insert 200. 【0054】 In one exemplary embodiment, the groove point P of the concave upper surface 262 m The insert may be positioned at a distance D from the rear surface 220 of the insert 200, where distance D is approximately equal to 25% to 50% of the total width of the insert 200 (e.g., front / rear dimensions), preferably 30% to 45% of the total width (e.g., front / rear dimensions), more preferably 35% to 40% of the total width of the insert 200. In one embodiment, distance D may be approximately 35% to 37% of the total width of the insert 200 (e.g., front / rear dimensions). In one exemplary embodiment, the concave upper surface 262 of the inner portion 260 may have a radius of curvature R in the range of 102% to 125% of the contact portion of the medial femoral condyle for the femoral component that is a fit. As those skilled in the art will understand, the radius of curvature may vary depending on the size (e.g., width) of the insert. 【0055】 In addition, groove point P on the concave upper surface 262 mBy arranging the front portion 210 closer to the rear portion 220, the insert 200 has a height H at the front lip portion 265. A The groove points P of the concave upper surface 262 are measured relative to each groove of the receiving femoral condyle in a cross-section representing the approximate edge of the femoral contact area (for example, the approximate mesial (or closest to the midline) edge of the femoral contact area on the insert, a cross-section approximately 13.5 mm from the midline of the insert). m Height H of the anterior lip 265 when measured from the tip of the anterior lip 265 A This may be 6.5 mm to 10 mm. In contrast, the insert 200 has a height H at the rear lip portion 267. p The height may be lower (for example, the height of the lip at the posterior lip portion 267 is lower than the height of the lip at the anterior lip portion 265). In one example embodiment, the groove point P of the concave upper surface 262 m Height H of the posterior lip 267, measured from the tip of the posterior lip 267. p This can be 3mm to 4mm. As those skilled in the art will understand, the height H at the anterior lip portion 265 A and height H in the posterior lip portion 267 p This can vary depending on the size of the insert (e.g., A / P width). 【0056】 As will be explained and illustrated in more detail below, the groove is located further back (for example, groove point P). m By incorporating an inner portion having a concave upper surface (for example, the bottom or lowest point of the concave upper surface 262 is positioned closer to the rear surface 220), and by increasing the height H of the front lip, A By incorporating this feature, the insert 200 is positioned and configured to provide improved stability for various grades of PCL defects compared to existing inserts on the market that have a median groove and a lateral convexity. With this positioning, the insert 200 is positioned and configured for use in knee prostheses where the patient is experiencing PCL functional loss or excision of the PCL. 【0057】 In contrast, as mentioned above, the outer portion 270 is at least partially a convex surface or curve. That is, for example, as best illustrated in Figure 10, which shows a cross-sectional view of the insert 200 passing through the outer portion 270, taken at a distance of about 24 mm from the midpoint of the insert 200, the outer portion 270 includes a double-centered upper surface 272 extending from the rear surface 220 to the front surface 210 (for example, the upper surface 272 of the outer portion 270 includes a double-centered curve), and at least partially of the upper surface 272 is a convex surface or curve. With this arrangement, in one embodiment, the double-centered upper surface 272 of the outer portion 270 may include a first rear section 272a, a second rear intermediate section 272b, a third intermediate section 272c, an optional fourth front intermediate section 272d, and a fifth front section 272e adjacent to the rear lip portion 276, but this is only one configuration, and the double-centered upper surface 272 may include more sections or fewer sections. 【0058】 In one embodiment, the first rear section 272a may form a rearward (e.g., concave) curve that begins to form a lipped region at the rear lip 276. During use, the size of the first rear section 272a expands as the insert size increases. The second rear intermediate section 272b and the fifth front section 272e may each include a concave surface or curve, while the third intermediate section 272c includes a convex surface or curve. 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. During use, the flat surface or section 272d extends rearward for a short distance from the fifth front section 272e before transitioning to the third intermediate section 272c. In one embodiment, the second rear intermediate section 272b may have a different radius of curvature compared to the first rear section 272a, which affects the position of the transition point between the first rear section 272a and the second rear intermediate section 272b, thereby affecting the change in inclination between the second rear intermediate section 272b and the third intermediate section, and / or the height H in the rear lip section 276 within the outer section 270. p It allows for increases and decreases. 【0059】 In one embodiment, according to one or more features of the present disclosure, groove point P of the double-centered upper surface 272 of the outer portion 270 LThis occurs at the transition point between the fifth pre-section 272e and the optional fourth pre-intermediate section 272d (for example, at point P). L (This refers to the point where the fifth front section 272e intersects with the adjacent fourth front intermediate section 272d). In other words, the groove point P of the double-centered upper surface 272 of the outer section 270. L It is located at the trailing end of a pre-concave radius curve (e.g., front section 272e). Groove point P L The groove point P may 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, the groove point P of the double-centered upper surface 272 of the outer portion 270 may be located. L The groove point P on the double-core upper surface 272 may be located closer to the front surface 210 of the insert 200 than to the rear surface 220. L The insert may be positioned at a distance D from the rear surface 220 of the insert 200, where distance D is approximately 40% to 75%, preferably 50% to 65%, of the total width of the insert 200 (e.g., front / rear dimensions). 【0060】 With this arrangement, groove points P of the outer portion 270 are determined according to one or more features of the present disclosure. L The groove point P of the inner portion 260. m It may be positioned closer to the front surface 210 of the insert 200 (for example, groove point P of the inner portion 260). m The groove point P of the outer portion 270 L (It is positioned closer to the rear surface of the insert than the other side.) For example, in one embodiment, groove point P of the outer portion 270 L The groove point P of the inner portion 260. m It may be positioned further forward by approximately 10–35 percent of the total distance between the rear and front. 【0061】 In one exemplary embodiment, the transition point T of the double-centered upper surface 272 of the outer portion 270 occurs at the point of transition to the rear convex portion (for example, the transition point between an arbitrarily selected fourth front intermediate section 272d and a third intermediate section 272c (for example, the transition point T is located at the point where the fourth front intermediate section 272d intersects the adjacent third intermediate section 272c)). Therefore, the transition point T is defined as the front starting point of the convex radius of the third intermediate section 272c (for example, at the rear end of the fourth front intermediate section 272d), while the groove point P L It is defined at the front end of the fourth front intermediate section 272d. In use, in one embodiment, groove point P L And the transition point T may be connected by a flat surface (e.g., an optional fourth pre-intermediate section 272d), so they may be positioned at the same height from the bottom surface of the insert. However, alternatively, if the double-centered upper surface 272 of the outer portion 270 lacks an optional fourth pre-intermediate section 272d, the groove point P L The transition point T may also be aligned with the A / P width. As shown in the figure, in one embodiment, the transition point T may be located at a distance T from the rear surface 220 of the insert 200, where the distance T is about 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). 【0062】 When used in this specification, groove point P L By defining the transition point T separately, alternative embodiments are possible in which the upper surface 272 includes an additional section or length of either another flat concave radius portion transitioning to a flat or convex curve, or a transition to a convex radius without any intermediate portion. 【0063】 With this arrangement, the insert 200 has a height H at the front lip portion 275 of the outer portion 270. A The device is arranged and configured to provide the following: In one exemplary embodiment, the groove point P is measured relative to each groove of the receiving femoral condyle in a cross-section representing the approximate edge of the femoral contact area (for example, the approximate mesial (or closest to the midline) edge of the femoral contact area on the insert, approximately 13.5 mm from the midline). LHeight H of the outer portion 270 at the front lip portion 275 when measured from the front lip portion 275 to the tip of the front lip portion 275 A The height may be 2.5 mm to 4.5 mm. In contrast, the insert 200 has a height H at the rear lip portion 276 of the outer portion 270. p This may include the height H of the rear lip portion 276. p The height H of the posterior lip portion 276 may be 0.5 mm to 1.5 mm. As those skilled in the art will understand, p This can vary depending on the size of the insert (e.g., A / P width). For example, the depth or height of the rear lip portion 276 may vary depending on the groove point P L The smallest insert size is approximately 1.5 mm lower than the maximum. During use, as the insert size increases, the rear lip becomes more prominent and rises slightly higher due to the additional first rear section 272a. For the largest size insert, the depth (or height of the rear lip) is at groove point P. L It is approximately 0.5 mm below that. 【0064】 In one exemplary embodiment, the foremost section or portion of the concave upper surface 272 of the outer portion 270 (e.g., the fifth anterior section 272e (Figure 10)) may have a radius of curvature R in the range of 155% to 225% of the radius of the contact portion of the lateral femoral condyle for the femoral component which is a fit. During use, the outer portion is more relaxed, and the outer radius of curvature is positioned and configured to facilitate movement (e.g., screw home during extension), in contrast to the radius of curvature of the inner portion which is positioned and configured to restrict movement. As those skilled in the art will understand, the radius of curvature may vary depending on the size (e.g., width) of the insert. 【0065】 An improved insert 200 for use in a knee prosthesis, such as a knee prosthesis 100, is provided according to one or more features of the present disclosure. For example, by incorporating a medial portion 260 having a concave upper surface 262 and a lateral portion 270 having a compound upper surface 272 which is at least a portion of a convex surface, an articular insert 200 is provided that is arranged and configured to facilitate the performance of cruciate ligament-preserving or cruciate ligament replacement TKA procedures, with options to better adapt to patient needs and various soft tissue conditions, which may affect knee replacement function and long-term clinical outcomes. 【0066】 By incorporating an inner portion 260 having a recessed upper surface 262 with a more posterior groove and an enlarged anterior lip, according to one or more features of the present disclosure, the insert 200 provides improved stability against various grades of PCL defects compared to existing inserts on the market having a median groove and an lateral convex portion (as is evident from Figures 13, 14, 18, and 19). Conversely, by incorporating an inner portion 260 having a recessed upper surface 262 and an lateral portion 270 having at least partial convexity, according to one or more features of the present disclosure, the insert 200 is arranged and configured to promote improved lateral posterior translation compared to existing inserts on the market having a recessed or flat lateral articulation (Figures 15, 16, 17, 20, 21, and 22). 【0067】 Furthermore, during use, insert 200 is positioned and configured to be implanted in procedures where the patient's PCL is preserved. Referring to Figures 13-17, insert 200 is used in knee prostheses where the patient's PCL is preserved. As is evident from the data in Figures 13-17, insert 200 functions similarly to the existing insert 1. During use, by utilizing insert 200 which preserves the patient's PCL, flexion can be maintained and the same amount of medial translation (as provided in Figures 13 and 14), lateral translation (as provided in Figures 15 and 16), and internal / external rotation (as provided in Figure 17) can be achieved. Posterior femoral retraction (e.g., translation) (Figures 15 and 16) and internal / external rotation (Figure 17) are improved compared to the more restrictive design (existing insert 2), which also provides additional A / P constraints when the PCL is preserved and the ligament's integrity is not initially intrinsic or becomes increasingly deficient postoperatively. 【0068】 Conversely, Figures 18–22 show that insert 200 can also be used in procedures to compensate for a patient's PCL. Referring to Figures 18–22, insert 200 is used in knee prostheses where a patient's PCL is compensated. As is evident from the data in Figures 18–22, insert 200 functions similarly to the existing insert 2, with some improvements. Medial intra-articular translation is similar to the more restrictive design (existing insert 2) with the advantage that the femoral implantation point is more anterior during elongation (as provided in Figures 18 and 19). In addition, these figures show improved stability compared to standard CR insert designs for PCL-compensated or severely deficient PCL conditions. Laterally, insert 200 facilitates improved posterior translation of the femur in deep flexion (as provided in Figures 20 and 21) and internal / external rotation (as provided in Figure 22) compared to the more restrictive insert 2. 【0069】 Referring to Figures 13–22, test data comparing an insert 200 conforming to one or more features of this disclosure (e.g., an insert 200 incorporating a medial portion 260 with a concave upper surface 262 having a more posterior groove and an enlarged anterior lip, and an lateral portion 270 that is at least partially convex) with existing inserts on the market and / or a normal knee are illustrated. As shown, insert 200 is compared with an existing insert (insert 1) incorporating a medial portion having a concave upper surface including a median groove and an lateral convex portion, and an existing insert (insert 2) incorporating concave upper surfaces in both the medial and lateral portions. 【0070】 Referring to Figure 13, the tibiofemoral kinematics illustrating the anterior / posterior translation within the medial portion of insert 200, compared to existing inserts 1 and 2, when used under PCL-preserving conditions, are illustrated. 【0071】 Referring to Figure 14, the translation of the medial femoral condylar arc relative to the tibia during knee flexion from 60 to 120 degrees is illustrated for insert 200 compared to existing inserts 1 and 2, when used under PCL-preserving conditions and compared to a normal knee. The values ​​in parentheses describe the position of the base of the medial femoral condylar arc relative to the tibia midline during full extension. 【0072】 Referring to Figure 15, the tibiofemoral kinematics illustrating the anterior / posterior translation within the lateral portion of insert 200, compared to existing inserts 1 and 2 on the market, when used under PCL-preserving conditions, are illustrated. 【0073】 Referring to Figure 16, the translation of the lateral femoral condylar arc relative to the tibia during knee flexion from 60 to 120 degrees with insert 200 compared to existing inserts 1 and 2, under PCL-preserving conditions and in a normal knee. The values ​​in parentheses describe the position of the base of the lateral condylar arc relative to the tibia midline in full extension. 【0074】 Referring to Figure 17, the tibiofemoral kinematics illustrating the internal / external rotation of insert 200 compared to existing inserts 1 and 2 when used under PCL-preserving conditions are illustrated. 【0075】 Referring to Figure 18, the tibiofemoral kinematics illustrating the anterior / posterior translation within the medial portion of insert 200, compared to existing inserts 1 and 2, when used under PCL compensatory conditions, are illustrated. 【0076】 Referring to Figure 19, the translation of the medial femoral condylar arc relative to the tibia during knee flexion from 60 to 120 degrees with insert 200 compared to existing inserts 1 and 2 when used in a PCL compensatory condition is illustrated. The values ​​in parentheses describe the position of the base of the medial femoral condylar arc relative to the midline of the tibia in full extension. 【0077】 Referring to Figure 20, the tibiofemoral kinematics illustrating the anterior / posterior translation within the lateral portion of insert 200, compared to existing inserts 1 and 2, when used under PCL compensatory conditions, are illustrated. 【0078】 Referring to Figure 21, the translation of the lateral femoral condylar arc relative to the tibia during knee flexion from 60 to 120 degrees with insert 200 compared to existing inserts 1 and 2 when used in a PCL compensatory condition is illustrated. The values ​​in parentheses describe the position of the base of the lateral condylar arc relative to the tibia midline during full extension. 【0079】 Referring to Figure 22, the tibiofemoral kinematics illustrating the internal / external rotation of insert 200 compared to existing inserts 1 and 2 when used in PCL compensatory conditions are illustrated. 【0080】 When in use, as described above, insert 200 can be used in conjunction with any suitable knee prosthesis currently known or to be developed in the future (e.g., femoral and tibial components). In addition, insert 200 can be manufactured from any suitable biocompatible material currently known or to be developed for use in the manufacture of orthopedic inserts, including plastic or polymer materials such as ultra-high molecular weight polyethylene. Furthermore, insert 200 may be constructed in any suitable form currently known or to be developed. For example, insert 200 may be machined, molded, or otherwise constructed as a one-piece integrated unit from a medically physiologically acceptable plastic such as ultra-high molecular weight polyethylene in various sizes to fit a typical patient range, or it may be custom-designed to fit a specific patient based on data provided by the surgeon after physical and radiological examinations of the particular patient. The material can be treated, for example, by radiation, chemical, or other techniques to modify its wear properties and / or strength or hardness. Various surface areas of the insert can be treated with radiation, chemicals, or other materials or techniques to enhance wear resistance, and can also be subjected to surface treatments suitable for such purposes and other purposes. 【0081】 When used, the insert 200 may be provided individually as part of a knee prosthesis, or as part of a kit including various sized inserts, tibial components, and / or femoral components. Alternatively, a patient-matched knee prosthesis may be provided, having a specific shape and / or other features of the implant customized to the anatomical structure of a particular patient. 【0082】 Terms such as top, bottom, upper, lower, inner, outer, front, back, proximal, and distal are used relatively in this specification. However, such terms are not limited to specific coordinate orientations, distances, or sizes, and are used to describe relative positions referring to specific embodiments. Such terms are not generally limited to the claims made herein. In relation to various embodiments of similar sections, parts, or components of this specification, any embodiment or feature of any illustrated or specifically described section, part, or any other component may be interchangeably applied to any other similar embodiment or feature illustrated or specifically described herein. 【0083】 While this disclosure refers to certain embodiments, numerous modifications, alterations, and changes are possible to the embodiments described without departing from the scope and realm of this disclosure as defined in the appended claims. Therefore, this disclosure is not intended to be limited to the embodiments described. Rather, these embodiments should be considered illustrative and not limiting in character. All changes and modifications within the spirit of the invention should be considered within the scope of this disclosure. This disclosure is given in its entirety as defined by the following claims and their equivalents. 【0084】 The above description has a wide range of applications. Any consideration of the embodiments is for illustrative purposes only and is not intended to suggest that the scope of this disclosure, including the claims, is limited to these embodiments. In other words, although exemplary embodiments of this disclosure are described in detail herein, it should be understood that the concepts of the present invention can be embodied and used in various other ways, and that the appended claims are intended to be interpreted to include such variations, unless limited by the prior art. 【0085】 As described herein, “Embodiments” (such as those illustrated in the accompanying drawings) are understood to mean exemplary representations of environments, articles, or components in which the disclosed concepts or features may be provided or embodied, or representations in which only the concepts or features may be provided or embodied. However, such exemplary embodiments should be understood as examples (unless otherwise stated), and other forms of embodying the described concepts or features, as understood by those skilled in the art when learning the concepts or features from this disclosure, are within the scope of this disclosure. In addition, the drawings may show one or more embodiments of a concept or feature together in a single embodiment of an environment, article, or component incorporating such concepts or features, and such concepts or features should be understood as independent and separate from each other (unless otherwise specified), shown together for convenience, and not intended to limit their existence or use together. For example, a feature illustrated or described as part of one embodiment may be used separately or in conjunction with another embodiment to bring about further embodiments. For this reason, this subject matter is intended to cover modifications and variations that fall within the scope of the accompanying claims and their equivalents. 【0086】 As used herein, elements or steps listed in the singular and preceded by the terms "a" or "an" should be understood not to exclude multiple elements or steps unless the exclusion of multiple elements or steps is explicitly listed. 【0087】 As used herein, the phrases “at least one,” “one or more,” and “and / or” are non-restrictive expressions that are both connective and disconnective in action. The terms “a” (or “an”), “one or more,” and “at least one” may be used interchangeably herein. References of connection (e.g., engagement, attachment, coupling, joining, and joining) should be interpreted broadly and may include intermediate members for movement between sets of elements and between elements unless otherwise indicated. Thus, references of connection do not necessarily presume that two elements are directly connected and in a fixed relationship with one another. References of identification (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to indicate importance or priority and are used to distinguish one feature from another. Drawings are for illustrative purposes only, and the relative dimensions, locations, order, and sizes reflected in the drawings attached herein may vary. 【0088】 The considerations described above are presented for illustrative and explanatory purposes and are not intended to limit the disclosure to the forms disclosed herein. For example, various features of the Disclosure are grouped together in one or more embodiments or configurations for the purpose of streamlining the Disclosure. However, it is understood that various features of a particular embodiment or configuration of the Disclosure may be combined in alternative embodiments or configurations. Furthermore, the following claims are incorporated herein by reference into the detailed description of the Invention, although each claim exists on its own as a separate embodiment of the Disclosure.

Claims

[Claim 1] It is a knee prosthesis, Femoral components including medial condylar surface, lateral condylar surface, and articular surface, Tibial components, including load-bearing components, An insert positioned between the articular surface and the load-bearing component, wherein the insert includes a front surface, a rear surface, an inner surface, an outer surface, an inner component, and an outer component. The inner component includes an upper surface that is arranged to contact the inner convex surface, and the upper surface of the inner component includes an inner groove point. The outer component includes an upper surface that is arranged to contact the outer condyle surface, and the upper surface of the outer component includes an outer groove point. The inner groove point is positioned closer to the rear surface than to the front surface. A knee prosthesis comprising an insert, wherein the inner groove point is positioned closer to the rear surface of the insert than the outer groove point. [Claim 2] The knee prosthesis according to claim 1, wherein the outer groove point is located closer to the front surface than to the rear surface. [Claim 3] The knee prosthesis according to claim 1 or 2, wherein the outer groove point is located approximately 10 to 35 percent forward of the total distance between the posterior surface and the anterior surface than the inner groove point. [Claim 4] The knee prosthesis according to any one of claims 1 to 3, wherein the outer groove point is located at a distance D from the rear surface, and the distance D is approximately 50 to 65 percent of the total distance between the front surface and the rear surface. [Claim 5] The knee prosthesis according to any one of claims 1 to 4, wherein the medial groove point is located at a distance D from the rear surface, and the distance D is approximately 30 to 45 percent of the total distance between the front surface and the rear surface. [Claim 6] The knee prosthesis according to any one of claims 1 to 5, wherein the medial groove point is located at a distance D from the rear surface, and the distance D is approximately 35 to 40 percent of the total distance between the front surface and the rear surface. [Claim 7] The knee prosthesis according to any one of claims 1 to 6, wherein the upper surface of the inner component includes a concave surface, and the upper surface of the outer component includes a bicentric curve in which at least one area includes a convex surface. [Claim 8] The knee prosthesis according to claim 7, wherein the concave surface of the inner component extends completely from the rear surface to the front surface. [Claim 9] The inner component is the front lip portion, and the height H measured from the inner groove point to the tip of the front lip portion is... Ａ A front lip portion and a rear lip portion, wherein the height H measured from the inner groove point to the tip of the rear lip portion ｐ It includes a posterior lip portion having a height H Ａ However, height H ｐ A knee prosthesis according to claim 7 or 8, which is larger than the knee prosthesis described in claim 7 or 8. [Claim 10] The height H of the prelip portion Ａ The height H of the rear lip portion is 6.5 mm to 10 mm. ｐ The knee prosthesis according to claim 9, wherein the diameter is 3 mm to 4 mm. [Claim 11] The knee prosthesis according to any one of claims 7 to 10, wherein the double-centered curve of the upper surface of the outer portion includes a front section containing a concave surface. [Claim 12] The knee prosthesis according to claim 11, wherein the double-centered curve of the upper surface of the outer component includes a concave posterior section positioned between the posterior surface and the convex section. [Claim 13] The knee prosthesis according to claim 12, wherein the double-centered curve of the upper surface of the outer component includes a concave posterior intermediate section located between the concave posterior section and the convex section. [Claim 14] The knee prosthesis according to claim 12, wherein the double-centered curve of the upper surface of the outer component includes a flat section located between the anterior concave section and the convex section. [Claim 15] The knee prosthesis according to claim 14, wherein the outer groove point is located in the transition area between the anterior concave section and the flat section. [Claim 16] The knee prosthesis according to any one of claims 7 to 14, wherein the double-centered curve of the upper surface of the outer component includes a transition point defined at the front end of the convex section, the transition point is located at a distance T from the rear surface, and the distance T is about 40% to 50% of the total distance between the rear surface and the front surface.

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