Femoral prosthesis and partial or total knee prosthesis

Abstract

To provide a knee prosthesis that is much better adapted to the need of any individual patient, thereby reducing the risk of chronic pains and / or discomfort.SOLUTION: A femoral prosthesis comprises: (a) two condylar portions comprising the medial and lateral condyles, having a bone-facing surface for abutting at least a part of each condyle and an articular surface opposite each bone-facing surface, each articular surface having a J-curve in a sagittal plane and an ML curve in a frontal plane and transverse planes; each articular surface having a condylar offset; (b) a trochlear portion, comprising a trochlear depth as well as lateral and medial trochlear elevations, having a bone-facing surface and an articular surface, each articular surface having a J-curve in a sagittal plane and an ML curve in a frontal plane and transverse planes; (c) the articular surface orientations of the distal and posterior condylar portions and the trochlea portion are independent and are mutually parallel or obliquely oriented (convergent or divergent).SELECTED DRAWING: Figure 21A

Description

Cross - reference to Related Applications

[0001] This application incorporates by reference and claims priority to U.S. Provisional Application No. 62 / 964,170, filed on January 22, 2020, and U.S. Provisional Application No. 62 / 964,182, filed on January 22, 2020, and all of its content is understood to contribute to the solution of the technical problems underlying the invention, and some of the features mentioned in this document are considered particularly important. Identification of Related Parties

[0002] The applicant for this intellectual property matter is Symbios Orthopedics SA, Switzerland. The inventors of the present invention described in this patent document are Vincent Reculer, a French national from Echallens, Switzerland, and Florent Prey, a French national from Preverenges, Switzerland. Other inventors may be added at the time of filing a regular national application. John B. Moeteli, and Vinci Partners LLC, Switzerland, act as agents for the applicant at the time of filing. Copyright and Legal Notice

[0003] Some of the material disclosed in this patent document is subject to copyright protection. The applicant has no objection to third - party facsimile reproduction of the patent document as disclosed in the records of the Patent and Trademark Office, but reserves all copyrights in any other case. Also, third - party patents or articles described in this application should not be considered as an admission that the present invention has no right to precede such material due to prior invention.

Background Art

[0004] Today's knee prostheses have been adapted from the perspective of industrial production and thus standardization. Such prior art prostheses have been considered satisfactory in terms of service life (more than 93% exceed 15 years), but customer satisfaction is low (only 70%). Due to such a situation, many patients who could benefit from prostheses delay surgery for fear of discomfort and pain risks, becoming more severely ill and consequently requiring more significant treatment. After knee replacement surgery, the behavior of standard prostheses, which is different from the anatomical behavior of the knee joints inherent to an individual, i.e., specific to each patient, causes chronic discomfort and pain in particular. When a patient's first knee is replaced with a prosthesis and the second knee is not replaced simultaneously, the use of prior art standard knee prostheses may cause unbalanced behavior between the replaced knee joint and the natural knee joint, accelerating the aging and / or deformation of the non-replaced knee joint, and ultimately necessitating the replacement of the second knee joint earlier.

[0005] Therefore, there is a need for a knee prosthesis that replaces a patient's natural knee joint in an anatomically personalized manner, minimizes the risks of discomfort and pain, and does not cause secondary damage to the other knee joint.

Disclosure of the Invention

[0006] Provided are a knee prosthesis and a method of selecting from an available knee prosthesis inventory or a 3D knee prosthesis model for a specific patient. The method includes: (a) parameterizing a knee prosthesis according to clearly defined and independent knee joint compartments; (b) generating a number of knee shapes in the form of 3D knee prosthesis models that replicate the 3D shape asymmetry of each individual's knee, thereby generating shapes that vary the shape parameters (surface and dimensions) of at least one of the compartments, enabling replication of the movement of essentially all patients' knees, and storing such 3D knee prosthesis models in a database; and (c) learning the patient's pathology and developing pre-pathological knee prosthesis criteria that match the patient's needs. The appropriate knee prosthesis is selected from the current knee prosthesis inventory or a number of knee shapes, and the optimally selected prosthesis or shape matches the patient's needs defined by learning.

[0007] In another embodiment, the method includes considering the patellar joint when selecting an appropriate 3D model.

[0008] The present invention provides a knee prosthesis that is much better suited to the needs of any individual patient than current state-of-the-art knee prostheses, and as a result reduces the risk of chronic pain and / or discomfort. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The accompanying drawings illustrate different embodiments of the subject matter of the present invention.

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[0010] It will be apparent to those skilled in the art that the elements shown in the drawings are disclosed for purposes of simplicity and clarity and are not necessarily drawn to scale. For example, in order to enhance the understanding of the present invention and its embodiments, the dimensions may be emphasized relative to other elements. Further, the terms "first", "second" and the like used herein are used to distinguish similar elements and do not necessarily indicate a sequential or chronological order. Also, the terms "front", "rear", "plane", "bottom" and the like in the specification and / or claims do not necessarily comprehensively represent a limited relative position. Those skilled in the art should understand that such terms may be replaced under appropriate circumstances such that the various embodiments disclosed in the present application are operable in orientations other than those clearly illustrated or described. Detailed Description of the Preferred Embodiments

[0011] The following description is illustrative in nature and is intended to describe the best mode of the invention known to the inventors at the time of filing of the present application, and is not intended to limit the scope of the invention in any way. As a result, the arrangement and / or function of all elements in the exemplary embodiments disclosed herein can be changed without departing from the spirit and scope of the present invention.

[0012] The present invention enables the recreation of a patient's knee joint as if it were natural, taking into account the entire movement behavior of the patient's knee joint (not only the current or pre-pathology, but also the patient-specific HKA (hip-knee-ankle) alignment. The patellar joint is also considered.

[0013] Referring to FIGS. 1A and 1B, the knee joint (1) of a patient during sitting (knee flexion) is shown, The femur (10) and the tibia (20) are joined via the medial meniscus (22) and the lateral meniscus (24), and the femur contacts the medial condyle (12) and the lateral condyle (14). The Applicant has identified that the natural relative movement of the femur with respect to the tibia can be described as a combination of sliding and rolling movements, including linear movements such as medial / lateral movement (110), anterior / posterior movement (120), superior / inferior movement (310), etc., and rotations such as flexion / extension (120), internal / external rotation (220), axial (internal / external) rotation (320), etc. The movement of the knee is characterized by movement following the femoral helical axis, which is a combination of the flexion / extension axis and the longitudinal axis. This resulting helical axis is due to the shape of the knee and the knee alignment. This combined movement varies from person to person and is modified by the patient's medical condition (pathology, trauma, etc.). The knee moves following the femoral helical axis, which is a combination of the flexion / extension axis and the longitudinal axis, and this resulting helical axis is due to the shape of the knee and the knee alignment.

[0014] Well-known prior art knee prostheses consider only anterior / posterior movement (120) and flexion / extension (120) rotation, resulting in a simpler prosthesis, but have the disadvantage that the surgeon has to implant a non-anatomic implant non-anatomically. Such prior art prostheses have been considered satisfactory in terms of service life (over 93% after 15 years), but customer satisfaction is low (70%). Due to such a situation, many patients who could benefit from the prosthesis delay surgery for fear of the risk of discomfort and pain. If the patient's sleep is disturbed by discomfort and pain, the patient seeks a knee prosthesis. The patient tries to manage with medication for as long as possible, but if the waiting period is too long, knee displacement and pathology increase, which may also impact ligament tension and collateral joints, making the surgery more difficult. In some countries, due to cost considerations, patients are very slow to go to the hospital, and in some cases, bilateral knee replacement has to be performed simultaneously (due to damage to the healthy knee caused by the load on the unhealthy knee due to the delay).

[0015] Recent prostheses use the same restrictions for anterior / posterior movement (120) and flexion / extension (120) rotation, but the inclination of the flexion / extension (120) rotation is created to achieve a movement closer to the natural movement of the patient's knee. Since such prostheses have only been used for a few years, their service life and patient satisfaction are not yet known. Nevertheless, even in this case, the surgeon attempts to anatomically implant a prosthesis that does not conform to the anatomy.

[0016] Next, referring to FIGS. 2A, 2B, and 2C, the present invention disclosed herein provides a broader view of the patient's structural anatomy. Humans not only have unique knee movements characterized by individual knee joint morphology (the patient-specific joint surface between the femur and tibia, or between the femur and patella), but also have individual HKA (hip-knee-ankle) alignments. Normal (FIG. 2A) alignment, also referred to as "balanced alignment" or "straight alignment," is predominant in the population, but significant variations are observed from structural varus (or bowlegs) (FIG. 2B) to structural valgus (or knock knees) (FIG. 2C).

[0017] In the current prior art, all patients should achieve normal alignment (Figure 2A), and the inclined installation of the prosthesis is considered to be able to fully accommodate the individual knee joints of the patients. Such alignment is also referred to as "mechanical alignment" and is characterized by the balanced alignment and the mechanical axes of the femur and tibia. The movement and articulation of the patella (40) are also ignored. Therefore, prior art knee prostheses are manufactured as standard specifications of very limited sizes, and as a result, the manufacturing cost can be suppressed. When using such prior art prostheses, difficulties arise in mechanically and anatomically installing prostheses that do not conform to anatomy. Therefore, many compromises have to be made in positioning and sizing, thereby sometimes resulting in prosthetic overhang (risk of pain and loss of mobility), or undersized prostheses (risk of sinking or loosening) implants, and new tensions and undesirable pressures may occur within the ligaments or bones that hold the joints together in the newly created knee joint. Friction between these elements may cause discomfort and pain to the patient.

[0018] Next, the method 3000 according to the present invention shown in FIG. 3 is composed of a plurality of steps and is not necessarily in the following order. In a first step 3002, a CT scan, X-ray, MRI, EOS (when loaded or unloaded, single-leg walking, two-leg walking, under varus / valgus pressure), or any other measuring device is used, and / or any method known in the art is applied to evaluate and / or measure the pre-operative state of the patient, and the following patient situations, (a) HKA alignment (see FIGS. 2A, 2B, 2C), and (b) relative movement of the femur with respect to the tibia (a combination of sliding and rolling movements shown in FIG. 1A) (c) contact surfaces and bone shapes of the femur and tibia, and (d) shape and position of the patella relative to the femur and tibia, and the contact surface of the patella with the femur, including at least one evaluation / measurement of.

[0019] In the second step 3004, the postoperative HKA alignment of the subject is defined according to the above sub-step (a) and the patient's anatomical history (if known).

[0020] In the third step 3006, the relative movement of the femur of the subject relative to the tibia after surgery (a combination of sliding and rolling movements) is defined according to the second step and the above sub-step (b).

[0021] In the fourth step 3010, the shape of the contact surfaces of the femur and tibia prostheses is defined according to the second and third steps, and the above sub-step (c).

[0022] In the fifth step 3012, the shape of the attachments of the femur and tibia prostheses is defined according to the fourth step and the above sub-step (c).

[0023] In the sixth step 3014, the postoperative position of the patella of the subject relative to the femur prosthesis and the tibia prosthesis is defined according to the second, third, and fourth steps, the above sub-step (d), and the patient's anatomical history (if known).

[0024] In the seventh step 3016, the shape of the contact surface between the femur prosthesis and the patella is defined according to the second, third, fourth, and sixth steps, and the above sub-step (d) (the contact surface only between the femur component and the patella component, not between the patella component and the tibia component).

[0025] In the eighth step 3020, the above definition defines a knee prosthesis adapted to the individual.

[0026] Next, the method 4000 according to the present invention shown in FIG. 4 is composed of a plurality of steps and is not necessarily in the following order. The method 4000 for selecting a 3D knee prosthesis model for a specific patient is - Step 4002: (a) Parametrizing the knee prosthesis according to clearly defined and independent knee joint compartments; - Step 4004: (b) Generating a number of knee shapes by varying the shape parameters (surface and dimensions) of at least one such compartment; consisting of An appropriate knee prosthesis is selected from the generated knee shapes to suit the patient's needs, and with the generated configuration, knee shapes with high variability are replicated. This knee shape replicates the 3D shape asymmetry of each individual's knee, and as a result, the movement of the patient's knee can be replicated. Regarding step 4002 above, for each compartment, parametrization is achieved such that two types of images / sketches can be adjusted. The first type involves personalizing the image / sketch of the joint defining the articular surface of each compartment by adapting the ML and AP guide curves at each surface (radius of curvature, offset, origin position of the relevant guide curve of the patient's knee frame), so as to match the 3D shape of the prosthesis surface to the patient's knee surface. The second type involves personalizing along the articular surface of the image / sketch of the dimensions (guide curve defining the outer limit), so as to accurately match the prosthesis dimensions around the entire joint to the patient's size. The orientation and position of such external boundary guide curves are defined by the parameters at each surface (radius, dimensions, origin position of the relevant guide curve to the patient's knee frame).

[0027] Next, the method 5000 according to the present invention shown in FIG. 5 is composed of a plurality of steps, not necessarily in the following order. The method 5000 creates a database of 3D knee prosthesis models, from which a 3D knee prosthesis model suitable for the needs of a specific patient is selected. The method includes the following multiple steps, not necessarily in the following order. - Step 5002: (a) Parametrizing the design configuration of the selected knee prosthesis to features corresponding to clearly defined and independent knee joint compartments. - Step 5004: (b) Generating a number of 3D knee prosthesis models corresponding to at least one compartment and replicating the 3D shape asymmetry of the sample population of an individual's knee by varying shape parameters such as surface, dimensions, etc. - Step 5006: (c) Inserting the generated models into a database to create a database of 3D knee prosthesis models with high variability. - Step 5010: (d) Learning the movement of the patient's knee using a 3D scan. - Step 5012: (e) Adjusting for pathology and optionally soft tissue effects to create a pre-pathological model assuming the movement of the patient's knee. - Step 5014: (f) Selecting one or more models that best replicate one or more pre-pathological models assuming the movement of the patient's knee defined by the 3D shape asymmetry of the patient's knee from an appropriate knee prosthesis inventory or a database of 3D knee prosthesis models. - Step 5016: (g) Creating the selected prosthesis model if a matching knee prosthesis is not in stock. - Step 5020: (h) Creating a prosthesis available for implantation.

[0028] Next, the method 6000 according to the present invention shown in FIG. 6 is composed of a plurality of steps and is not necessarily in the following order. A knee prosthesis manufactured from a 3D model selected after the application of the method 6000 is provided, and the method 6000 - Step 6002: (a) Analyzing the current and pre-pathological knee behavior of the patient and the HKA alignment of the patient. - Step 6004: (b) Selecting an appropriate 3D model from a comprehensive database of 3D models that change knee morphology, where each 3D model conforms to a known morphology and adapts to manufacturing limitations and requirements. - Step 6006: (c) Creating a selected 3D model corresponding to a manufacturable and essentially custom knee prosthesis adapted to the 3D structural anatomy of an individual patient, enabling recreation of a knee joint as if it were natural. including.

[0029] Next, referring to FIGS. 7A and 7B, the femur is shown in the axial plane view, and in a set of pre-arthritic or native (knees without any pathology) knees, the variations are very wide from the following viewpoints. · Knee dimensions · Knee shape · Knee size · Limb alignment

[0030] Among people with healthy knee joints, · Structural varus alignment (bow-legged shape) · Structural valgus alignment (knock-kneed shape) · Structural balanced alignment (straight-legged shape) Some people have any of these.

[0031] Such a deviated limb alignment (varus or valgus) of a healthy knee is considered not a misalignment but simply a structural limb alignment deviation.

[0032] Even for knees of the same dimension, the shape varies significantly because there are also very different parameters within the joint among the same ethnic groups.

[0033] The main parameters that functionally act on the joint are as follows. · Alpha (α): The angle between FMA and BCD · DCA: The angle between TEA and BCD · PCA: The angle between TEA and BCP · ATA: The angle between TEA and TL · SA: Sulcus Axis (connecting KC to TG) WL: Whiteside Line (connecting KC to TGL)

[0034] Such all parameters can vary from each other by 15° or more (each angulated parameter varies from its average value by up to 7.5°, meaning that the variability range of each parameter among healthy populations is up to 15°, and is estimated to be a Gaussian curve).

[0035] The causes of such variations are genetics (inheritance), ontogeny, pre-skeletal development postural and / or behavioral and / or body weight, gender, somatotype (endomorph, ectomorph, mesomorph), or ethnicity (daily life behaviors associated with deep knee flexion).

[0036] Each individual knee has a deep relationship between the knee geometry and the surrounding soft tissue envelope, especially with the cruciate ligaments, collateral ligaments, and retinacular ligaments. When the knee shape changes after implanting a knee prosthesis, the relationship between the ligament insertions and the joint surfaces changes, making it difficult or even impossible to correctly balance the knee not only between the medial and lateral compartments but also during extension, flexion, and mid-flexion.

[0037] Next, referring to FIGS. 8A and 8B, a deep relationship is shown between knee alignment, knee size and shape, and ligament insertions and lengths (collateral ligaments, cruciate ligaments, retinacular ligaments). The medial collateral ligament 422 attaches the femur 410 to the tibia 420. The cruciate ligament 424 attaches the femur 410 to the tibia 420. The lateral collateral ligament 432 attaches the femur 410 to the fibula 430. The medial patellar retinaculum 442 attaches the femur 410 to the patella 440 medially. The lateral patellar retinaculum 444 attaches the femur to the patella 440 laterally.

[0038] Next, FIGS. 9A - 9C show the femur implant of the knee prosthesis of the present invention, and the following elements are shown for reference. Bone-facing surface 510 Articular surface 520, Condylar part 522 of the medial condyle, Condylar part 524 of the lateral condyle, Pulley part 526, Medial eminence 532, Lateral eminence 534, Pulley depth 536, Inner and outer curves 540, Inner end 542 of the inner and outer curves, Outer end 544 of the inner and outer curves, J-curve condyle 550, Anterior part 552 of the J-curve condyle, Posterior part 554 of the J-curve condyle, J-curve pulley 560

[0039] Next, FIGS. 10A to 10C show a knee prosthesis of the present invention, and the following elements are shown. Femoral component 610, Inner femoral bone facing surface 612, Outer articular surface 614, Tibial insertion component 620, Corresponding articular surface 624, Tibial tray component 630, Inner tibial bone facing surface 632, Patellar component 640, Inner patellar bone facing surface 642, Patellar articular surface 644.

[0040] Next, referring to FIGS. 11A to 11D, a comparison between a prior art knee prosthesis and the knee prosthesis of the present invention is clearly visualized.

[0041] (Comparison with a standard (off-the-shelf) knee prosthesis and limitations of the present system) Since knee prostheses or knee implants are non-anatomical (in that they only roughly match the anatomical movements of the human knee) and must be implanted in a way that more or less matches the anatomy of the patient's knee joint, there are many significant simplifications and compromises that cannot occur in the design of knee prostheses.

[0042] The initial goal was to mechanically optimize the implant of the prosthesis and extend the service life of the prosthesis. Such knee prostheses have been designed to have a symmetrical spherical shape and thickness and to always be mechanically implanted (resected at 90° to the mechanical axis in the coronal plane) for balanced limb realignment.

[0043] Subsequently, compromising on the shape, size, and alignment of the average knee and limb morphological types, the dogmatic concept has been constrained within the size range of knee prostheses by different companies, and the concept includes the following. · The number of sizes is usually limited to 10. However, since it is known that the smallest size for the white race does not fit the corresponding size for the Asian race, it does not achieve a wide range of dimensional variations from small knees to very wide knees. Furthermore, most companies increase the size by adding intermediate sizes between two sizes rather than increasing the sizes of both the large and small poles. · The medial / lateral / anteroposterior ratio has been considered fixed, but it is now known that it varies significantly by race and has been well described regarding prosthesis protrusion or component downsizing. · The sagittal shape of the femoral condyles and / or trochlea (J-curve) has usually been simplified as a single, double, or multiple radius, but it is now known that some patients have a single or multiple radius J-curve. · The femoropatellar joint has usually been simplified with a fixed-orientation groove axis, but it is now known that the groove axis is not equally oriented in such a way when the distal femur is varus or valgus. · Fifthly, except for the Smith & Nephew Journey knee with a 2.5-mm fixed offset for the distal medial condyle and posterior condyle, condylar shift is hardly considered, but it is now known that the slope of the joint line varies significantly by race and between the distal head and the posterior condyle.

[0044] Today, more than 93% of knee prostheses have clinical results showing that they can last for 15 years after implantation. However, 30% of the patient population complains of dissatisfaction after total knee replacement, namely pain, loss of mobility, or abnormal kinematics.

[0045] Moreover, an additional challenge today is that those who require total knee replacement are younger and still very active. Generally, knee function and global satisfaction across different ethnic groups have become more important. Thus, the recent trend is to do the best in anatomically installing knee prostheses that do not conform to anatomy. Although the function is improved, there is a risk that the service life of the knee prosthesis will be shortened, and as a result, the risk of early component loosening becomes high.

[0046] (Knee implants (standard knee implants, as well as patient-specific, personalized / custom implants) are as follows) Next, the knee prostheses shown in FIGS. 9A - 9C and FIGS. 10A - 10C include a femoral component, a tibial tray component (with an insertion part), and a patella component, and are designed to define a standard range of knee prostheses or patient-specific knee prostheses based on patient-specific data (obtained from literature, cadavers, 3D images).

[0047] The inner bone-facing surface of the femoral component conforms to the corresponding surface of the femoral head. Alternatively, it conforms to optimized bone resection on one or more femoral heads. However, the outer joint surface of the component is enhanced to incorporate a smooth surface with a substantially constant radius in the coronal plane. The corresponding joint surface of the tibial tray (insertion) has a surface contour that matches the outer joint surface in the coronal plane.

[0048] In certain embodiments, the joint surface of the component incorporates a sagittal curvature that exactly matches the existing or healthy sagittal radius of the patient. (Recent knee prostheses) · Symmetrical condyles · In the case of the distal bone and the posterior condyle, the thickness between the medial condyle and the lateral condyle is the same, but the thickness between the distal bone and the posterior condyle may be different. · Tangent of the distal bone and the posterior condyle parallel to the flexion axis of the knee prosthesis · Trochlear eminence parallel to the tangent of the fixed posterior condyle (axial plane) · Without condylar shift (except for the 2.5 mm offset of S&N company) · Approximately 6° to the outside, or the fixed groove axis is oriented offset to the outside

[0049] The inventive activity of the present invention also includes changing the medial femur - tibia joint, the lateral femur - tibia joint, and the femur - patella joint independently of each other. This is defined as the following variable parameters. (Personalized knee prosthesis) · Offset of the distal bone (not a fixed value) = alpha distal angle αd · Posterior condyle offset (not a fixed value) = alpha posterior angle αp · Offset of the trochlear eminence (not a fixed value) · αd is equal to αp, or not equal, and is equal to the trochlear eminence angle (ATA), or not equal · DCA is equal to αd, or not equal · PCA is equal to αp, or not equal · SA is not a fixed value (groove axis = γ1) · WL is not a fixed value (White side line = γ2)

[0050] (Differences between the standard specification (STD), off-the-shelf (OTS) prosthesis and the personalized knee prosthesis of the present invention) Next, referring to FIGS. 11A to 11D, the significant differences between the STD (OTS) prosthesis and the personalized knee prosthesis of the present invention are shown. FIGS. 11A (coronal plane) and 11C (axial plane) show the standard knee femoral components defined by the distal and posterior prosthesis joint lines (DCA, PCA), which are parallel to the prosthesis knee flexion axis and have a fixed groove axis and Whiteside line orientation (SA, WL). The orientation of the trochlear line is also parallel or has a fixed angle (ATA) during flexion.

[0051] In particular, referring to FIGS. 11B (coronal plane) and 11D (axial plane), a personalized knee prosthesis is shown, where the distal and posterior prosthesis joint lines are defined as being inclined (or not perpendicular) to the prosthesis knee flexion axis. Its distal and posterior angles (DCA, PCA) are independent of each other and have an independent groove axis and Whiteside line orientation (SA, WL). The orientation of the trochlear line changes independently (variable angle) (ATA) up to the posterior condylar line during flexion.

[0052] Next, referring to FIGS. 12A to 12K, the main geometrical parameters defining the femoral part of the knee prosthesis of the present invention are as follows. 802 Femur 810 Femoral implant 812 Medial condyle 814 Lateral condyle 820 Mediolateral dimension (ML) 822 Medial condyle dimension from the femoral mechanical axis (FMA, 836) 824 Lateral condyle dimension from the femoral mechanical axis (FMA, 836) 826 Femoral anatomical axis (FAA) 830 Intercondylar axis 832 Medial condylar axis defined most distally from the femoral mechanical axis (FMA, 836) 834 Lateral condylar axis defined most distally from the femoral mechanical axis (FMA, 836) 836 Femoral Mechanical Axis (FMA) 838 HKS: Angle between FAA826 and FMA836 846 Transepicondylar Axis (TEA) 852 Medial Condyle Surface 854 Lateral Condyle Surface 856 Bicondylar Distal Tangent (BCD) 858 Angle between FMA836 and BCD856

[0053] In particular, referring to FIGS. 12A and 12B, for any medial-lateral dimension (ML) 820, the medial condyle dimension 822 and the lateral condyle dimension 824 measured from the femoral mechanical axis (FMA) 836 are at most twice as large as the other in the coronal plane (distal head) or the axial plane (posterior condyle).

[0054] Similarly, the medial condyle axis 832 and the lateral condyle axis 834 measured from the femoral mechanical axis (FMA) 836 differ from each other by at most 10 mm.

[0055] FIGS. 12C to 12K show examples of variations of the posterior condyle and the distal head enabled by the knee prosthesis of the present invention.

[0056] Next, referring to FIGS. 12C, 12D, 12H, and 12I, the condyles 812, 814 relative to each other are adapted to have a variation of at most 10 mm.

[0057] Next, referring to FIGS. 12E, 12F, 12J, and 12K, the angle 858 between the femoral mechanical axis (FMA) 836 and the bicondylar distal tangent (BCD) 856 varies by at most 15° medially or laterally, distally or posteriorly.

[0058] Next, referring to FIGS. 12G, 12H, 12I, 12J, and 12K, the variations and differences between the condyles 812, 814 are adapted independently of the angle between the femoral anatomical axis (FAA) 826 and the femoral mechanical axis (FMA) 836. In other words, all adaptations of the condyles 812, 814 are made independently of the size of the prosthesis and regardless of whether the patient's hip-knee-ankle (HKA) alignment is normal, varus, or valgus.

[0059] Next, referring to FIGS. 13A - 13C, the femoral portion of the knee prosthesis of the present invention is shown, and further parameters related to the shape, surface, and contour are defined as follows. 912 Medial condyle 914 Lateral condyle 936 Femoral mechanical axis (FMA) 946 Trans - epicondylar axis (TEA) 952 Medial condyle surface 953 Trochlear surface 954 Lateral condyle surface 962 Radius of curvature of the medial condyle surface in the coronal and transverse planes 963 Radius of curvature of the trochlear surface in the coronal plane 964 Radius of curvature of the lateral condyle surface in the coronal and transverse planes 972 Shape of the medial condyle surface in the sagittal plane (medial condyle J - curve) 973 Shape of the trochlear surface in the sagittal plane (trochlear J - curve) 974 Shape of the lateral condyle surface in the sagittal plane (lateral condyle J - curve) 982 Medial contour angle of the anterior surface of the femoral implant in the coronal plane 984 Lateral contour angle of the anterior surface of the femoral implant in the coronal plane 992 Medial contour angle of the posterior surface of the femoral implant in the transverse and coronal planes 994 Lateral contour angle of the posterior surface of the femoral implant in the transverse and coronal planes

[0060] Next, referring to FIGS. 13A and 13B, the radii of curvature 962 of the inner condylar surface in the coronal and transverse planes, the radius of curvature 963 of the trochlear surface in the coronal plane, and the radii of curvature 964 of the outer condylar surface in the coronal and transverse planes can be adjusted independently of each other, independently of the size of the prosthesis, and independently of whether the patient is normal, varus, or valgus, and independently of the patient's hip-knee-ankle (HKA) alignment. The important point is that the contour (outer dimension of the implant) is resurfaced without protruding or exposing the resection area. The radii of curvature 962 of the inner condylar surface in the coronal and transverse planes, the radius of curvature 963 of the trochlear surface in the coronal plane, and the radii of curvature 964 of the outer condylar surface in the coronal and transverse planes can vary from 15 mm to 65 mm. All contour angles 982, 984, 992, 994 related to the front and rear surfaces of the femoral implant can be adjusted independently of each other, independently of the size of the prosthesis, and independently of whether the patient is normal, varus, or valgus, and independently of the patient's hip-knee-ankle (HKA) alignment. All contour angles 982, 984, 992, 994 related to the front and rear surfaces of the femoral implant can vary from 0° to 50°.

[0061] Next, referring to FIG. 13C, the shape of the inner condylar surface (inner condyle J curve) 972 in the sagittal plane, the shape of the trochlear surface (trochlear J curve) 973 in the sagittal plane, and the shape of the outer condylar surface (outer condyle J curve) 974 in the sagittal plane can be adjusted independently of each other, independently of the size of the prosthesis, and independently of whether the patient is normal, varus, or valgus, and independently of the patient's hip-knee-ankle (HKA) alignment. The shape of the inner condylar surface (inner condyle J curve) 972 in the sagittal plane, the shape of the trochlear surface (trochlear J curve) 973 in the sagittal plane, and the shape of the outer condylar surface (outer condyle J curve) 974 in the sagittal plane may consist of one radius or a combination of two or more radii, and their dimensions can vary from 15 mm to 65 mm. When using a combination of radii, the transition from one radius to the next is smoothed using a spline curve or any other suitable curve, such as applying a curve or surface fitting algorithm provided by, for example, "SOLIDWORKS (registered trademark)".

[0062] Next, referring to FIGS. 14A to 14L, the femur portion of the knee prosthesis of the present invention is adapted to any bone resection such as planar (FIGS. 14A, 14B), inclined (FIGS. 14C, 14D), curved (FIGS. 14E, 14F), offset (FIGS. 14G, 14H), double inclination (FIGS. 14I, 14J), or any other bone resection adapted to the individual needs of the patient. The bone resection is performed using a saw (FIG. 14K), rolling (FIG. 14L), or any other suitable technique known in the art.

[0063] Next, referring to FIGS. 15A to 15E, the main geometric parameters defining the femur implant and the tibia insertion component of the knee prosthesis of the present invention are defined as follows. 1102 Femur 1110 Femur implant 1112 Medial condyle 1114 Lateral condyle 1120 Mediolateral dimension (ML) 1122 Medial condyle dimension from the femur mechanical axis (FMA, 1136) 1124 Lateral condyle dimension from the femur mechanical axis (FMA, 1136) 1126 Femur anatomical axis (FAA) 1130 Intercondylar axis 1132 Medial condyle central axis from the femur mechanical axis (FMA, 1136) 1134 Lateral condyle central condyle axis from the femur mechanical axis (FMA, 1136) 1136 Femur mechanical axis (FMA) 1146 Trans epicondylar axis (TEA) 1152 Medial condyle surface of the femur implant 1153 Pulley surface of the femur implant 1154 Lateral condyle surface of the femur implant 1156 Bicondylar distal tangent (BCD) of the femur implant 1160 Tibia insertion component 1162 Medial condyle corresponding surface of the tibia insertion component 1163 Tibial Insert Component's Patellar-Facing Surface 1164 Tibial Insert Component's Lateral Condyle-Facing Surface 1166 Tibial Insert Component's Two-Condyle Distal Tangent

[0064] In the knee prosthesis of the present invention, the tibial insert component 1160 is created to match the femoral implant 1110 (where "match" means applying known curve / surface fitting and smoothing techniques, such as using "SOLIDWORKS (registered trademark)", between the described shapes and interacting across adjacent bone compartments). In other words, the tibial insert component 1160 shares with the femoral implant 1110 the same or substantially the same inner and outer dimensions 1120, the same or substantially the same medial condyle dimension 1122 from the femoral mechanical axis, the same or substantially the same lateral condyle dimension 1124 from the femoral mechanical axis, the same or substantially the same intercondylar axis 1130, the same or substantially the same medial condyle central axis 1132 from the femoral mechanical axis, the same or substantially the same lateral central condyle axis 1134 from the femoral mechanical axis, the same or substantially the same supracondylar axis 1146, and the medial condyle surface 1152 of the femoral implant fits the medial condyle - facing surface 1162 of the tibial insert component, the patellar surface 1153 of the femoral implant fits the patellar - facing surface 1163 of the tibial insert component, the lateral condyle surface 1154 of the femoral implant fits the lateral condyle - facing surface 1164 of the tibial insert component, the two - condyle distal tangent 1166 of the tibial insert component is made to fit the two - condyle distal tangent 1166 of the tibial insert component.

[0065] Next, referring to FIGS. 15B - 15E, a plurality of examples of adapting the knee prosthesis of the present invention to the needs of individual patients are shown.

[0066] In particular, FIG. 15B shows the knee prosthesis of the present invention in the case of structural varus of the femur. The femoral implant 1110 has a distal lateral condyle shorter than the distal medial condyle, and an offset 1172 occurs between the condyles. An essentially identical offset 1172 is replicated within the tibial insertion component 1160.

[0067] Next, FIG. 15C shows the knee prosthesis of the present invention in the case of structural valgus of the femur. The femoral implant 1110 has a distal lateral condyle longer than the distal medial condyle, and an offset 1174 occurs between the condyles. The same or essentially the same offset 1174 is replicated within the tibial insertion component 1160.

[0068] Next, FIG. 15D shows the knee prosthesis of the present invention in the case of structural varus of the femur. The femoral implant 1110 has an opening angle 1182 from the distal lateral condyle to the distal medial condyle, and the same or essentially the same angle 1182 is replicated within the tibial insertion component 1160.

[0069] Next, FIG. 15E shows the knee prosthesis of the present invention in the case of structural valgus of the femur. The femoral implant 1110 has an opening angle 1184 from the distal medial condyle to the distal lateral condyle, and the same or essentially the same angle 1184 is replicated within the tibial insertion component 1160.

[0070] In the knee prosthesis of the present invention, the offsets 1172, 1174 can vary from 0 to 10 mm, and the angles 1182, 1184 can vary from 0° to 15°.

[0071] Next, FIGS. 16A to 16E show schematic coronal cross-sectional views combining the tibial insertion, tibial tray, and keel geometry of the knee prosthesis of the present invention. The main parameters in the coronal plane are defined as follows. 1262 Inner condyle corresponding surface of the tibial insertion component 1263 Pulley corresponding surface of the tibial insertion component 1264 Outer condyle corresponding surface of the tibial insertion component Two distal tangents of the tibial insertion component 1266

[0072] In fact, the tibial insertion, tibial tray, and keel are realized in one or more parts and assembled by any suitable technique known in the art, and such assembly is done before or during the surgery. For the purposes of this description, the elements are shown as being created as one part with different portions, namely (i) the articular surface of the tibial insertion including the medial condyle corresponding surface 1262, the trochlea corresponding surface 1263, and the lateral condyle corresponding surface 1264, (ii) the bone-facing surface 1230 of the tibial tray, and (iii) the keel 1240. To meet the needs of individual patients, any orientation angle, any offset, and any combination thereof in the knee prosthesis of the present invention are adapted to the tibial insertion, tibial tray, and keel.

[0073] Next, the keel 1240 shown in FIG. 16B is oriented at an angle 1242 rather than being orthogonal to the bone-facing surface 1230 to meet the needs of individual patients.

[0074] Next, the keel 1240 shown in FIG. 16C is oriented at an angle 1242 rather than being orthogonal to the bone-facing surface 1230, and the bone-facing surface 1230 is oriented at an angle 1232 to meet the needs of individual patients. Similar to this example, the thinner medial insertion thickness makes the knee more prone to turning inwards.

[0075] Next, the keel 1240 shown in FIG. 16D is oriented at an angle 1242 rather than being orthogonal to the bone-facing surface 1230, the bone-facing surface 1230 is oriented at an angle 1232, and the lateral condyle corresponding surface 1264 shows an offset 1265 to meet the needs of individual patients.

[0076] Next, the keel 1240 shown in FIG. 16E is oriented at an angle 1242 rather than being orthogonal to the bone-facing surface 1230 to accommodate the needs of an individual patient. The bone-facing surface 1230 is oriented at an angle 1232, and the two-distal tangents 1266 are oriented at an angle 1267. In the knee prosthesis of the present invention, the offset 1265 varies from 0 to 10 mm, and the orientation angles 1232, 1242, 1267 can vary up to 12°.

[0077] Typically, the offset varies in the medial-lateral or anterior-posterior dimension from -10° to +10°, and can be oriented up to 12° about the longitudinal axis of the keel.

[0078] Next, FIGS. 17A-17I show a schematic coronal cross-sectional view combining the geometries of the tibial insert 1320, tibial tray 1330, and keel 1340 of the knee prosthesis of the present invention, shown in the same manner as being created as one part 1300. In reality, the tibial component 1300 of the knee prosthesis of the present invention is realized in one or more parts and assembled by any suitable technique known in the art, and such assembly is done before or during surgery. In such a simplified drawing, only the sagittal J-curve 1310 is shown, but this J-curve 1310 also shows the surface of the tibial component 1300, and the medial condyle, trochlea, or lateral condyle of the femoral implant of the present invention is connected at the interface.

[0079] The sagittal J-curve 1310 is adapted to fit the corresponding surface of the femoral implant of the present invention, so that the function of the knee prosthesis of the present invention meets the needs of an individual patient. For this purpose, the sagittal J-curve 1310 may consist of one radius, but may also consist of a combination of two radii 1312, 1313 (FIGS. 17A, 17B, 17C, 17F), three radii 1312, 1313, 1314 (FIGS. 17D, 17G), or more radii 1312, 1313, 1314, 1315 (FIGS. 17E, 17H, 17I), and its dimensions can vary from 15 mm to 80 mm.

[0080] To fit the tibia of an individual patient, the keel 1340 of the tibial component 1300 of the knee prosthesis of the present invention is disposed at the center of the tibial component 1300 in the sagittal plane (Figs. 17A, 17D, 17E, 17F, 17G, 17H), and shows an offset 1342 in the direction of the front part of the tibia (Fig. 17B) or in the direction of the rear part of the tibia (Figs. 17C, 17I). In the knee prosthesis of the present invention, the offset 1342 can vary from 0 to 10 mm.

[0081] For the same purpose of fitting the tibia of an individual patient, the bone-facing surface 1332 of the tibial component 1300 of the knee prosthesis of the present invention is oriented at an angle 1344 in the sagittal plane (Figs. 17F, 17G, 17H, 17I). In the knee prosthesis of the present invention, the angle 1344 can vary up to 12°.

[0082] The tibial component 1300 of the knee prosthesis of the present invention can combine any of the features described in this disclosure to better match the needs of an individual patient (Fig. 17I).

[0083] Normally, the offset can vary from -10° to +10° in the medial-lateral or anterior-posterior dimension and can be oriented up to 12° about the longitudinal axis of the keel.

[0084] Next, referring to Fig. 18, the parameters defining the contour 1410 of the tibial component 1400 are as follows. 1412 Medial condyle 1414 Lateral condyle 1422 Medial anterior condyle 1424 Lateral anterior condyle 1432 Medial posterior condyle 1434 Lateral posterior condyle 1442 Anteroposterior dimension of the medial anterior condyle (APam) 1444 Anteroposterior dimension of the lateral anterior condyle (APal) 1452 Anteroposterior dimension of the medial posterior condyle (APpm) 1454 Anteroposterior dimension of the lateral posterior condyle (APpl) 1462 Anteroposterior dimension of the medial condyle (APm) 1464 Anteroposterior dimension of the outer condyle (APl) 1470 Mediolateral dimension (ML) 1472 Mediolateral dimension of the inner condyle (MLm) 1474 Mediolateral dimension of the outer condyle (MLl)

[0085] In the knee prosthesis of the present invention, all such parameters are adapted to meet the needs of individual patients. In such a prosthesis, the mediolateral dimension 1470 varies from 40 mm to 150 mm, and the mediolateral dimensions 1472 and 1474 of the condyles both independently vary from 15 mm to 70 mm, and the anteroposterior dimensions 1442 and 1444 of the condyles can both independently vary from 30 mm to 70 mm.

[0086] Next, the tibial tray 1530 of the knee prosthesis of the present invention shown in FIGS. 19A to 19E is adapted to meet the needs of individual patients (optimized component coverage and anchorage). In the coronal plane, the bone-facing surface 1532 exhibits a specific orientation angle 1534, and the surface to which the tibial insert is attached can exhibit a specific offset 1535 (FIGS. 19B, 19C), or another orientation angle 1536 (FIGS. 19D, 19E). In the knee prosthesis of the present invention, the angles 1534 and 1536 vary from -12° to +12°, the offset 1535 varies from 0 to 10 mm in the medial and / or lateral dimensions, and can be oriented up to 45°. The tibial tray 1530 of the knee prosthesis of the present invention can combine any of the features described in this disclosure to match the needs of individual patients.

[0087] Next, the tibial tray 1630 of the knee prosthesis of the present invention shown in FIGS. 20A - 20D is adapted to any osteotomy geometry to meet the needs of an individual patient. In the coronal plane, the bone - facing surface 1632 is created to have a specific resection angle 1634 on the medial side (FIG. 20A) or the lateral side (FIG. 20B), or a resection step 1635 on the medial side (FIG. 20C) or the lateral side (FIG. 20D). In the knee prosthesis of the present invention, the angle 1634 varies from - 12° to + 12°, the step 1635 varies from 0 to 10 mm on the medial and / or lateral sides, and can be oriented up to 45°. The tibial tray 1630 of the knee prosthesis of the present invention can combine any of the features described in this disclosure to match the needs of an individual patient.

[0088] Next, referring to FIGS. 21A - 21C, in the coronal plane, the parameters defining the geometry of the patella component of the knee prosthesis of the present invention are as follows. 1852 Medial condyle surface of the femur implant 1853 Trochlear surface of the femur implant 1854 Lateral condyle surface of the femur implant 1862 Articular surface of the patella component corresponding to the medial condyle 1863 Articular surface of the patella component corresponding to the trochlea 1864 Articular surface of the patella component corresponding to the lateral condyle 1870 Inner - outer dimension of the patella component 1872 Inner - outer dimension of the medial side of the patella component 1874 Inner - outer dimension of the lateral side of the patella component

[0089] The geometry of the patella component of the knee prosthesis of the present invention is adapted to suit the needs of an individual patient. The articular surfaces 1862, 1863, 1864 of the patella component are created to fit the corresponding surfaces 1852, 1853, 1854 of the femoral component, taking into account the patient's hip-knee-ankle (HKA) alignment, whether normal, varus, or valgus. As an example, if the femoral component has an offset (1872 in FIG. 21C, 1874 in FIG. 21B) between the distal lateral condyle and the distal medial condyle, the offsets 1872, 1874 are replicated within the patella component.

[0090] Next, FIGS. 22A and 22B show the patella component of the knee prosthesis of the present invention. To match the needs of an individual patient, the inner and outer surfaces (FIG. 22A) are symmetric or asymmetric between the inner and outer compartments, and the front and rear surfaces (FIG. 22B) are symmetric or asymmetric between the front and rear compartments. FIG. 22A is a side view of the inner and outer compartments. FIG. 22B is a side view of the front and rear compartments. The four compartments are either symmetric or not symmetric.

[0091] Next, referring to FIG. 23, the parameters defining the contour 2010 of the patella component 2000 are as follows. 2022 Anterior medial compartment 2024 Anterior lateral compartment 2032 Posterior medial compartment 2034 Posterior lateral compartment 2042 Medial anteroposterior dimension (APm) 2044 Lateral anteroposterior dimension (APl) 2052 Anteroposterior dimension (APam) of the anterior medial compartment 2054 Anteroposterior dimension (APal) of the anterior lateral compartment 2062 Anteroposterior dimension (APpm) of the posterior medial compartment 2064 Anteroposterior dimension (APpl) of the posterior lateral compartment 2070 Mediolateral dimension (ML) Inner and outer dimensions inside (MLm) of 2072 Inner and outer dimensions outside (MLl) of 2074

[0092] In the knee prosthesis of the present invention, all such parameters are adapted to suit the needs of individual patients. The width and height of each of the four compartments (inner, outer, front, rear) are specified to be within the range from 8 mm to 30 mm. The values are independent of the thickness of the patella and are at least 6 mm or more.

[0093] (Main features of the present invention) The design specifications of the present invention for the distal and posterior condyles are such that when attached to each other for the trochlear part of the femoral component, they realign the pathologic limb as in the pre-pathologic state and reshape the joint surface to be as close as possible to the pre-arthritic shape and size of the knee joint, which is a personalized feature. (Different types of correction) · From the pathologic limb alignment offset to the pre-arthritic limb alignment · From the pathologic knee joint surface to the pre-arthritic knee joint surface (two condyles and trochlea), which is related to the inner and outer curves of the joint surface and the sagittal J-curves of both the condyles and the trochlea. · From the pathologic femur (distal, posterior, and middle), proximal tibia, and trochlear joint line to the corresponding pre-arthritic joint line (= condyle offset, trochlea offset between the inner and outer compartments) · From the pathologic distance between the trochlear depth and the inner and outer trochlear ridges to the corresponding pre-arthritic distance · From the pathologic coronal distance between the sagittal axis of the condyle and the trochlea in the middle of the knee to the corresponding pre-arthritic distance

[0094] Supplementary correction from the native or pre-arthritic limb alignment and knee shape (or used internally to avoid outliers from the perspective of alignment and shape, and to define normal and abnormal in terms of alignment and shape within that range, thereby indicating what to replicate and adjust) is · If the pre-arthritis limb alignment is mechanically unstable (due to excessive offset, varus or valgus postoperative HKA of more than 5°, HKA < 175° or HKA > 185°, or the risk of component loosening due to unbalanced load sharing during excessive abduction or adduction moments), correction of the limb alignment is applied to limit the global alignment at 175° < postoperative HKA < 185°. · If the pre-arthritis knee joint line is mechanically unstable (excessively inclined condyles, postoperative FMA of more than 5°, FMA < 85° or FMA > 95°, TMA < 85° or TMA > 95°, with the risk of component loosening due to unbalanced load sharing), correction of the condylar offset is applied to limit the inclination of the condyles and the proximal tibia to 5° (85° < FMA, TMA < 95°). The same applies when the medial or lateral condyles are underdeveloped (hypoplastic) or when there is excessive bone wear of the condyles. · If correction of the pre-arthritis limb alignment is required, restricted or hybrid alignment is targeted, meaning that the postoperative limb alignment is an intermediate alignment between the anatomically offset pre-arthritis alignment and the balanced postoperative alignment (in this situation, a compromise is made with the FMA (distal femoral joint line inclination)). This compromise is shifted / reported posteriorly to take the balance of correction during full flexion. · If the pre-arthritis lateral trochlear eminence is too smooth, causing the patella to be unstable (patellar dislocation) during flexion, a lateral wall (at least 5 mm) is constructed to protect and accurately center the patella during flexion. · If the pre-arthritis tibia slope is too excessive or insufficient (excessive descending slope or ascending slope), resulting in loss of mobility or causing excessive hyperextension (backward extension) of the associated knee joint laxity, correction is systematically applied so that the posterior tibia slope is within the range of 0° < TPS < 10°.

[0095] (Method for creating a personalized prosthesis) Next, the method 7000 according to the present invention shown in FIGS. 24A to 24F does not necessarily follow the following order. The method 7000 for creating a natural and personalized prosthesis includes at least one, or all of the following steps. - Step 7002: (a) Measuring the preoperative 3D HKA alignment of the knee. - Step 7004: (b) Replicating the postoperative 3D HKA realignment to the pre-arthritis HKA (if not an outlier). - Step 7006: (c) Defining the postoperative 3D HKA realignment to the corrected pre-arthritis HKA (if it is an outlier). - Step 7010: (d) Measuring the preoperative and postoperative dimensions of the distal femur. - Step 7012: (e) Replicating the size of the correct AP prosthesis femur so that the implant cannot rotate (or tilt, or bend) by 10° or more in the sagittal plane. - Step 7014: (f) Measuring the preoperative FMA distal posterior and TMA (joint line). - Step 7016: (g) Replicating the postoperative FMA and TMA inclination to the pre-arthritis FMA and TMA inclination (if not an outlier), and replicating the pre-arthritis femoral torsion. - Step 7020: (h) Defining the postoperative FMA and TMA inclination to the corrected pre-arthritis FMA and TMA inclination (if it is an outlier), and according to an algorithm that outputs personalized postoperative parameter values by obtaining anatomical inputs from landmarks in each of the three planes of the planning matrix (which calculates the preoperative dimensions and angles that define the morphological and phenotypic forms of the disease state), and adapting the femoral torsion according to the two types of images / sketches for limb realignment and knee shape (dimensions, joint surfaces). - Step 7022: (i) Measuring the preoperative TL inclination and trochlear depth. - Step 7024: (j) Define which part of the final slope on the bone is targeted (resection orientation) and which part is incorporated into the implant (offset) according to the rules disclosed in the planning matrix. - Step 7026: (k) Duplicate the postoperative TL slope to the pre-arthritic TL slope (if not an outlier) and duplicate the trochlear depth. - Step 7030: (l) Define the postoperative TL slope to the corrected pre-arthritic TL slope (if an outlier), and duplicate the trochlear depth by adding an outer ridge to the trochlea. - Step 7032: (m) Duplicate the postoperative condylar and trochlear JL curves to the pre-arthritic JL curve (if not an outlier). - Step 7034: (n) Define the postoperative condylar and trochlear joint line curves to the corrected pre-arthritic JL curve (by correcting the JL curves of the outer condyle in case of hypoplasia or both condyles in case of sagittal deformities such as retroversion, large flexion, etc. if an outlier). - Step 7036: (o) Duplicate the postoperative condylar and trochlear medial-lateral curves to the pre-arthritic ML (if not an outlier). - Step 7040: (p) Define the postoperative condylar and trochlear ML curves to the corrected pre-arthritic ML curve (by correcting the ML curves of the outer condyle or both condyles in case of sagittal deformities such as retroversion, large flexion, etc. if an outlier). - Step 7042: (q) Measure the distance from each condylar axis to the middle of the knee and duplicate this distance. - Step 7044: (r) Define the outer limit of the articular surface of the condyles and trochlea (contour) to avoid prosthesis protrusion or reduction. - Step 7046: (s) Measure the preoperative posterior tibial slope. - Step 7050: (t) Duplicate the postoperative posterior tibial slope (TPS) to the corrected pre-arthritic TPS if an outlier. - Step 7052: A step of defining the rotation of the tibial component by measuring the angle with respect to the anterior tibial tubercle (TTA), i.e., the AP axis, and by the axis (ML axis) passing through the centers of two circles depicting the medial and lateral tibial surface geometries. - Step 7054: A step of defining the AP and ML positions of the tibial keel and accurately centering the keel on the metaphysis and / or diaphysis of the tibia. - Step 7056: A step of defining the outer limit of the contour of the tibial component (towards the tibial edge) to avoid prosthesis protrusion (risk of collision with surrounding soft tissues and causing pain) or undersizing (risk of sinking and requiring revision). - Step 7060: A step of measuring the distance (difference at extension) between the distal femur resection and the proximal tibia resection to consider the global thickness of the implant.

[0096] Next, the method 8000 according to the present invention shown in FIG. 25A is not necessarily in the following order. Different procedures are shown in the method 8000. - Step 8002: (a) Place an order for fabrication. - Step 8004: (b) Transfer the image. - Step 8006: (c) Authenticate the image. - Step 8010: (d) Create a bone model. - Step 8012: (e) 3D planning, optionally supported by the product database 8014 and / or the CAO software 016. - Step 8020: (f) Design a patient-specific resection guide, optionally supported by the product database 8014 and / or the CAO software 016. - Step 8022: (g) Fabricate. - Step 8024: (h) Deliver. - Step 8026: (i) Perform surgery.

[0097] Next, referring to FIG. 25B, a sketch / image 8500 of the knee prosthesis of the present invention created according to the procedure of FIG. 25A is shown.

[0098] Next, referring to FIGS. 26A - 26D, the segmentation and parameterization of the femoral component are shown in more detail. These drawings show the medial anterior femur - patella compartment 2602, the lateral anterior femur - patella compartment 2604, the medial distal femur - condyle compartment 2606, the lateral distal femur - condyle compartment 2610, the medial posterior femur - condyle compartment 2612, and the lateral femur - condyle compartment 2614.

[0099] As will be understood by those skilled in the art, the present invention is implemented as a system, apparatus, or method. In one embodiment, the present invention is a computer - implemented method, and a task - specific program is encoded in a medium for selecting a suitable knee prosthesis for a particular patient. The computer includes a CPU / processor, memory, input, and output devices, which are operably coupled to perform one or more of the method steps described herein.

[0100] In all embodiments described herein selected from a plurality of 3D knee prostheses, it should be understood that for each component of the knee prosthesis (femoral component, tibial component, tibial insert, patellar component) to generate substantially all of the shape structures that exhibit the worldwide anatomical variability of the normal knee joint, a specific parameterized model is composed from sketches / images. The parameterized model is divided into compartments (e.g., for the femoral component, the medial distal condyle compartment, the medial posterior condyle compartment, the lateral distal condyle compartment, the lateral posterior condyle compartment, the medial trochlear compartment, the lateral trochlear compartment). In each of these independent components, a sketch / image is defined to replicate the shape and dimensions of the corresponding parts of the knee joint surface and prosthesis contour. These sketches / images are defined in each plane (coronal plane, sagittal plane, and transverse plane), enabling replication of the shape and dimensions of the knee prosthesis and knee joint in each plane of these planes. Each of these sketches / images is defined by fixed values and parameterized values (mathematical functions). The parameterized values are dynamically linked to a calculation table that defines the relationships between each independent compartment and describes the 3D variability of each of the compartments. Each prosthesis component structure (shape and dimensions) generated by the parameterized model and the calculation table replicates the anatomical variability of the normal knee joint.

[0101] Also, in each sub-step of the method for selecting a 3D knee prosthesis model described herein, a planning algorithm is used to be able to select a unique patient-specific component structure for each patient from this vast family of prosthesis configurations stored in the database, and it should be understood that the shape and size of the prosthesis best match the movement of the pre-arthritic patient's knee joint. In the first step, anatomical landmarks are identified at the hip, knee, and ankle joints (and also the upper body) to define the patient's pathological leg and knee morphological and phenotypic types. In the second step, a 3D planning algorithm composed of a matrix specific to each surface defines specific corrections to define limb alignment and pathological knee shape, and to replicate the pre-arthritic knee alignment and knee joint shape. Normal (mean + / - 2 standard deviations in each parameter) during knee prosthesis selection can essentially always be achieved using these inputs, but outliers are not tolerated and abnormal (at least 2 standard deviations above the mean for at least one parameter) prosthesis knee shapes are not created. In the third step, the algorithm selects a unique patient-specific prosthesis knee size from all knee structures and repositions, replicates the pre-arthritic knee joint (shape and dimensions) by positioning the components directly in the correct 3D orientation and alignment.

[0102] In another embodiment, a non-transitory information storage medium having features of a knee prosthesis and an encoded selection program is provided. When the program is executed, a method is implemented that instructs a processor to assist a user in selecting a 3D knee prosthesis for a specific patient. The encoded method is (a) using a parameterization module to parameterize a knee prosthesis according to clearly defined and independent knee joint compartments, and (b) Using a model generator, generate a number of knee shapes in the form of 3D knee prosthesis models that replicate the 3D shape asymmetry of a large number of individual knee samples, save the same in a database, and thereby generate shapes that vary the shape parameters (surface and dimensions) of at least one of the compartments, enabling the movement of essentially all patients' knees to be well replicated, and save the 3D knee prosthesis model in the database in association with the shape parameters and asymmetry of each model, enabling comparison between the asymmetry of the patient's knee and the asymmetry of the 3D knee prosthesis model; (c) After learning the pathology of the patient and developing pre-pathological knee prosthesis criteria that match the needs of the patient, search the database that compares the large number of knee shapes based on the best match of the asymmetry of each model to identify candidate matches; (d) Displaying the candidate matches and their attributes on an output device; (e) Providing a method for selecting the best match from the identified appropriate candidate matches; (f) Optionally placing a custom order if the selected knee prosthesis is not in stock; Including.

[0103] When processing is mentioned in the present application, for example, artificial intelligence including but not limited to neural circuits and / or machine learning algorithms, etc., can be used to assist in the analysis of the patient's current anatomy, calculate the most likely pre-pathological anatomy of the patient, assist in the selection within a database of appropriate prostheses (e.g., by applying pattern recognition and classification algorithms), and / or assist in the design of the patient-specific prosthesis.

[0104] Also, the system of the present application is intended for the use, sale, and / or distribution of all articles, services, or information having functions similar to those of the present application.

[0105] The specification and drawings of this application are to be understood as illustrative rather than restrictive, and all improvements described in this application are intended to be included within the scope of the invention claimed in this application. Therefore, the scope of the invention of this application should be determined not from the mere examples described above, but by the appended claims (the current claims, claims corrected or added later, or legally equivalent thereto). All steps described in the claims of any method or process are executable in any order unless otherwise specified, and are not limited to the specific order described in the claims. Furthermore, the elements and / or components described in the claims of the apparatus can also be assembled or operationally configured with various substitutions that yield substantially the same results as the invention of this application. Generally, the invention of this application is not limited to the specific configurations described in the claims.

[0106] The benefits, advantages, and solutions described in this application should not be considered as essential, necessary, or indispensable features or elements of any or all of the claims.

[0107] The terms "consisting of", "composed of", and other similar expressions used in this application are used to represent a non-exhaustive list of elements, and the devices, processes, methods, articles, or configurations of the invention composed of that list of elements do not necessarily include only the described elements, but may also include other elements described in this specification. Also, expressions such as "including", "comprising", or "essentially including" are not intended to limit the scope of the invention to only the recited elements unless otherwise specified. Combinations or improvements of the above-described elements, materials, or structures used in the implementation of the invention can also be changed or adapted to other designs by those skilled in the art without departing from the general principles of the invention.

[0108] The patents and documents cited above are incorporated herein by reference to the extent not inconsistent with the present disclosure, unless otherwise stated.

[0109] Other features and embodiments of the invention are described in the appended claims.

[0110] Furthermore, it should be considered that the present invention is composed of all possible combinations of all the features described in this specification, the appended claims and / or the drawings, which are considered to have novelty, inventive step and industrial applicability.

[0111] The present invention can be summarized by the following feature set. 1. A method for selecting a 3D knee prosthesis model for a specific patient, comprising: (a) parameterizing the knee prosthesis according to clearly defined and independent knee joint compartments; (b) generating a number of knee shapes in the form of 3D knee prosthesis models that replicate the 3D shape asymmetry of each individual's knee, thereby generating shapes that vary the shape parameters (surface and dimensions) of at least one of said compartments, enabling the replication of the movement of essentially all patients' knees, and storing said 3D knee prosthesis models in a database that enables comparison between the asymmetry of the patient's knee and the asymmetry of the 3D knee prosthesis model, associating each model with its shape parameters and asymmetry; (c) learning the patient's pathology and developing pre-pathological knee prosthesis criteria that match the patient's needs; and selecting, from said number of knee shapes, a suitable knee prosthesis that best matches the patient's needs based on the best match of the asymmetry of each model, such that the selected shape best conforms to the patient's criteria. 2. The method according to feature set 1, further comprising the step of optionally using a planning algorithm to select a suitable knee prosthesis based on the best match of the asymmetry of each model from said number of knee shapes, such that the selected shape best conforms to the patient's criteria. 3. The method according to the above feature set, wherein the selected 3D knee prosthesis model is used to create a suitable prosthesis for the patient. 4. The method according to the above feature set, wherein the surgeon makes the created prosthesis available for implantation. 5. The design specification of the present invention for the distal posterior femoral component to the trochlear portion is used to re-align the pathological limb in the same manner as before the pathology when attached to each other, and to re-form the joint surface as close as possible to the pre-arthritic shape and size of the knee joint, and is used to personalize the method according to Feature Set 1 having the feature of 6. A method for creating a database of 3D knee prosthesis models and selecting a 3D knee prosthesis model that matches the needs of a specific patient, comprising: (a) parameterizing the design configuration of the selected knee prosthesis into features corresponding to clearly defined and independent knee joint compartments; (b) generating a number of the 3D knee prosthesis models corresponding to at least one of the compartments by varying shape parameters such as surface, dimensions, etc. to replicate the 3D shape asymmetry of the sample set of the individual's knee; (c) inserting the generated models into the database, thereby creating the database of 3D knee prosthesis models having high variability; (d) learning the movement of the patient's knee using a 3D scan; (e) adjusting for the pathology and optionally the influence of soft tissues to create a pre-pathological model assuming the movement of the patient's knee; (f) optionally using a planning algorithm to select one or more models that best replicate one or more of the pre-pathological models assuming the movement of the patient's knee defined by the 3D shape asymmetry of the patient's knee from the available knee prosthesis inventory or the database of 3D knee prosthesis models; (g) creating the selected prosthesis model if no matching knee prosthesis is in stock; (h) creating the prosthesis available for the implant and the method comprising. 7. (a) analyzing the current and pre-pathological knee behavior of the patient and the HKA alignment of the patient; (b) Optionally, select an appropriate 3D model from a comprehensive database of 3D models that vary knee morphology using a planning algorithm, each 3D model being in a known form and adapted to manufacturing limitations and requirements, and (c) Create the selected 3D model adapted to the 3D structural anatomy of the individual patient and corresponding to an essentially custom knee prosthesis that can be manufactured, thereby enabling recreation of the knee joint as if it were natural, and Provide a knee prosthesis created from the 3D model selected after applying a method including. 8. The following steps (a) In a loaded or unloaded state, using a CT scan, X-ray, MRI, EOS, or any other measuring device, and / or any method known in the art, at least during single-leg walking, two-leg walking, under varus / valgus stress, (i) Measure the HKA alignment, and (ii) Measure the relative movement of the femur with respect to the tibia (a combination of sliding and rolling movements), and (iii) Measure the contact surfaces and bone shapes of the femur and tibia, and (iv) Measure the shape and position of the patella relative to the femur and tibia, and the contact surface of the patella with the femur, to measure the preoperative state of the patient including. (b) Define the postoperative HKA alignment of the subject according to (ai) and the patient's anatomical history (if known), and (c) Define the relative movement of the femur with respect to the tibia (a combination of sliding and rolling movements) of the subject postoperatively according to (b) and (aii), and (d) Define the shape of the contact surfaces of the femur and tibia prostheses according to (b), (c), and (aiii), and (e) Define the shape of the attachments of the femur and tibia prostheses according to (d) and (aiii), and (f) Define the position of the patella of the subject postoperatively with respect to the femur prosthesis and the tibia prosthesis according to (b), (c), (d), (f), (aiv), and the patient's anatomical history (if known). (g) Defining the shape of the contact surface between the femoral prosthesis and the patella according to (b), (c), (d), (f) and (aiv) (the contact surface is only between the femoral component and the patella component, not between the patella component and the tibial component), and (h) Merging all the above definitions into a knee prosthesis adapted to an individual; A method according to the present invention comprising the above steps. 9. The method according to one of Feature Sets 1 to 4, wherein the 3D scan is a video scan of the patient's knee in motion. 10. The method according to one of Feature Sets 1 to 4, wherein the known joint compartment includes at least one of the following compartments: an extension compartment, a flexion compartment, a medial compartment, a lateral compartment, a femoro-tibial compartment, and a femoro-patellar compartment. 11. The method according to one of Feature Sets 1 to 4, wherein the joint of the patella is taken into account when selecting the 3D model. 12. A prosthesis created according to one of Feature Sets 1 to 4. 13. The knee prosthesis of the present invention is adapted to the case of structural femoral varus, such that the femoral prosthesis (1110) has a distal lateral condyle shorter than the distal medial condyle, creating an offset (1172) between the condyles, and the same offset (1172) is replicated within the tibial insertion component (1160). The method according to one of Feature Sets 1 to 4. 14. The knee prosthesis of the present invention is adapted to the case of structural femoral valgus, such that the femoral prosthesis (1110) has a distal lateral condyle longer than the distal medial condyle, creating an offset (1174) between the condyles, and the same offset (1174) is replicated within the tibial insertion component (1160). The method according to one of Feature Sets 1 to 4. 15. The method according to one of Feature Sets 1 to 4, wherein the knee prosthesis of the present invention is adapted for the case of structural varus of the femur, the femur prosthesis (1110) has an opening angle (1182) from the distal lateral condyle to the distal medial condyle, and the same angle (1182) is replicated within the tibial insertion component (1160). 16. The method according to one of Feature Sets 1 to 4, wherein the knee prosthesis of the present invention is adapted for the case of structural valgus of the femur, the femur prosthesis (1110) has an opening angle (1184) from the distal medial condyle to the distal lateral condyle, and the same angle (1184) is replicated within the tibial insertion component (1160). 17. The method according to one of Feature Sets 1 to 4, wherein in the knee prosthesis of the present invention, the offset (1172, 1174) varies from 0 to 10 mm, and the angle (1182, 1184) varies from 0° to 15°. 18. During sizing of the prosthesis, the radius of curvature (962) of the medial condyle surface in the coronal and transverse planes, the radius of curvature (963) of the trochlear surface in the coronal plane, and the radius of curvature (964) of the lateral condyle surface in the coronal and transverse planes can be adjusted independently of each other, independently of the size of the prosthesis, and independently of whether it is normal, varus, or valgus, and independently of the hip-knee-ankle (HKA) alignment of the patient. The method according to one of Feature Sets 1 to 4. 19. The method according to one of Feature Sets 1 to 4, wherein the contour (the outer dimension of the prosthesis) is adjusted to avoid protrusion or exposure of the resection area and resurface. 20. The method according to one of Feature Sets 1 to 4, wherein the contour angles (982, 984, 992, 994) of the front and rear surfaces of the femur prosthesis can be adjusted independently of each other, independently of the size of the prosthesis, and independently of whether it is normal, varus, or valgus, and independently of the hip-knee-ankle (HKA) alignment of the patient. 21. The method according to one of Feature Sets 1 to 4, wherein the contour angles (982, 984, 992, 994) of the front and rear surfaces of the femur prosthesis vary from 0° to 50° in order to obtain desirable knee kinematics and to adapt to the size of the patient. 22. The shape of the medial condyle surface in the sagittal plane (medial condyle J curve) (972), the shape of the trochlear surface in the sagittal plane (trochlear J curve) (973), and the shape of the lateral condyle surface in the sagittal plane (lateral condyle J curve) (974) are independent of each other, independent of the size of the prosthesis, and can be adjusted independently of whether the patient is normal, varus, or valgus, and independent of the patient's hip-knee-ankle (HKA) alignment, the method according to one of feature sets 1 to 4. 23. The shape of the medial condyle surface in the sagittal plane (medial condyle J curve) (972), the shape of the trochlear surface in the sagittal plane (trochlear J curve) (973), and the shape of the lateral condyle surface in the sagittal plane (lateral condyle J curve) (974) may consist of one radius or a combination of two or more radii, and their dimensions can vary from 15 mm to 65 mm, the method according to one of feature sets 1 to 4. 24. When using a combination of radii, the transition from one radius to the next is smoothed using a spline curve or any other suitable curve, the method according to any of the above feature sets. 25. The femoral part of the knee prosthesis of the present invention is adapted to any osteotomy selected from a group of resections adapted to the individual needs of the patient, consisting of a plane, an inclination, a curvature, an offset, a double inclination, the method according to any of the above feature sets. 26. The osteotomy is by saw or rolling to adapt to the individual needs of the patient, the method according to the above feature set. 27. The following steps (a) Measuring the preoperative 3D HKA alignment of the knee; (b) Replicating the postoperative 3D HKA realignment to the pre-arthritis HKA (if not an outlier); (c) Defining the postoperative 3D HKA realignment to the corrected pre-arthritis HKA (if an outlier); (d) Measuring the preoperative and postoperative dimensions of the distal femur; (e) Replicating the correct AP prosthesis femoral size so that the implant cannot rotate (or incline or flex) by more than 10° in the sagittal plane; (f) Measuring the preoperative FMA distal posterior and TMA (joint line); (g) Replicating the postoperative FMA and TMA slopes to the pre - arthritis FMA and TMA slopes (if not outliers), and replicating the pre - arthritis femoral torsion; (h) Defining the postoperative FMA and TMA slopes to the corrected pre - arthritis FMA and TMA slopes (if outliers), and adapting the femoral torsion according to the planned matrix; (i) Measuring the preoperative TL slope and trochlear depth; (j) Defining, according to the rules disclosed in the planned matrix, which part of the final slope is made on the bone (orientation of the resection) and which part is integrated into the implant (offset); (k) Replicating the postoperative TL slope to the pre - arthritis TL slope (if not outliers), and replicating the trochlear depth; (l) Defining the postoperative TL slope to the corrected pre - arthritis TL slope (if outliers), and replicating the trochlear depth by adding an outer ridge to the trochlea; (m) Replicating the postoperative condylar and trochlear JL curves to the pre - arthritis JL curve (if not outliers); (n) Defining the postoperative condylar and trochlear joint line curves to the corrected pre - arthritis JL curve (if outliers, by correcting the JL curve of the outer condyle in case of hypoplasia or both condyles in case of sagittal deformities such as retroversion, large flexion, etc.); (o) Replicating the postoperative condylar and trochlear medial - lateral curves to the pre - arthritis ML (if not outliers); (p) Defining the postoperative condylar and trochlear ML curves to the corrected pre - arthritis ML curve (if outliers, by correcting the ML curve of the outer condyle or both condyles in case of sagittal deformities such as retroversion, large flexion, etc.); (q) Measuring the distance from between the axes of each condyle to the middle of the knee and replicating the distance; (r) Defining the outer limit (contour) of the articular surfaces of the condyles and trochlea to avoid prosthesis protrusion or reduction; (s) Measuring the posterior tibial slope before surgery; (t) If it is an outlier, replicating the postoperative posterior tibial slope (TPS) to the pre - arthritic corrected TPS; (u) Defining the rotation of the tibial component by measuring the angle with respect to the anterior tibial tubercle (TTA), i.e., the AP axis, and by the axis (ML axis) passing through the centers of two circles depicting the medial and lateral tibial surface geometries; (v) Defining the AP and ML positions of the tibial keel and accurately centering the keel on the tibial metaphysis and / or diaphysis; (w) Defining the outer limit (to the tibial edge) of the contour of the tibial component to avoid prosthesis protrusion (risk of colliding with surrounding soft tissues and causing pain) or undersizing (risk of sinking and requiring revision); (x) Measuring the distance (difference at extension) between the distal femur resection and the proximal tibia resection to account for the global thickness of the implant. A method of creating a natural and personalized implant, including at least one, or all, of the above. 28. The tibial insert, the tibial tray, and the keel, which are components of the prosthesis of the present invention, each consisting of one or more parts and assembled before or during surgery, and are created according to one of Feature Sets 1 to 4. 29. At least one of the components is (a) One element selected from one of the following groups of elements: (i) The articular surface (1262) of the tibial insert including the medial condyle - corresponding surface (ii) The trochlea - corresponding surface (1263) (iii) The lateral condyle - corresponding surface (1264) (b) The bone - facing surface (1230) of the tibial tray, and (c) The keel part (1240), The prosthesis according to the above - mentioned feature set. 30. The prosthesis according to the above set of features, wherein any desired orientation angle, offset, and any combination thereof are adapted to the tibial insertion, the tibial tray, and the keel so as to best meet the needs of the individual patient. 31. The prosthesis according to any one of the above two sets of features, wherein the tibial insertion, the tibial tray, and the keel are each formed of one or more elements. 32. The prosthesis according to any of the above sets of features, wherein the keel (1240) is formed so as not to be orthogonal to the bone-facing surface (1230) and is oriented at a selected angle (1242) to meet the needs of the individual patient. 33. The prosthesis according to any of the above sets of features, wherein the keel (1240) is oriented at the angle (1242) rather than being orthogonal to the bone-facing surface (1230), and the bone-facing surface (1230) is oriented at the angle (1232) to meet the needs of the individual patient. 34. The prosthesis according to the above set of features, wherein the medial insertion thickness is made thinner so that the knee is oriented valgus. 35. The prosthesis according to any of the above sets of features, wherein the keel (1240) is oriented at a selected angle (1242) rather than being orthogonal to the bone-facing surface (1230), the bone-facing surface (1230) is oriented at another selected angle (1232), and the lateral condyle corresponding surface (1264) exhibits an offset (1265) to meet the needs of the individual patient. 36. The prosthesis according to any of the above sets of features, wherein the keel (1240) is oriented at a selected angle (1242) rather than being orthogonal to the bone-facing surface (1230), the bone-facing surface (1230) is oriented at a second selected angle (1232), and the two-condyle distal tangent (1266) is oriented at a third selected angle (1267) to meet the needs of the individual patient. 37. The prosthesis according to any of the above sets of features, wherein the offset (1265) varies from 0 to 10 mm, and the orientation angles (1232, 1242, 1267) can vary up to 12°. 38. The prosthesis according to the above set of features, wherein the offset varies from -10° to +10° in the inner-outer or front-rear dimension and can be oriented up to a maximum of 12° about the longitudinal axis of the keel. 39. The prosthesis according to any of the above sets of features, wherein the sagittal J curve (1310) is adapted to fit the corresponding surface of the femur prosthesis of the present invention so that the function of the knee prosthesis of the present invention matches the needs of the individual patient. 40. The prosthesis according to the above set of features, wherein the sagittal J curve (1310) is essentially of a single radius. 41. The prosthesis according to the second last set of features, wherein the sagittal J curve (1310) is essentially a combination of two or more radii (1312, 1313, 1314, 1315), and its dimensions are in the range of 15 mm to 80 mm. 42. For fitting to the tibia of the individual patient, in the sagittal plane, the keel (1340) of the tibia component (1300) of the knee prosthesis of the present invention is arranged at the center of the tibia component (1300) and optionally shows an offset (1342) in the anterior direction of the tibia or in the posterior direction of the tibia. The prosthesis according to any of the above sets of features. 43. The prosthesis according to the above set of features, wherein the offset (1342) can vary from 0 to 10 mm. 44. The prosthesis according to the second last set of features, wherein the offset varies from -10° to +10° in the inner-outer or front-rear dimension and is oriented up to a maximum of 12° about the longitudinal axis of the keel. 45. For the same purpose of fitting to the tibia of the individual patient, in the sagittal plane, the bone-facing surface (1332) of the tibia component (1300) of the knee prosthesis of the present invention is oriented at a selectable angle (1344) that can vary up to a maximum of 12°. The prosthesis according to the above set of features. 46. The articular surfaces (1862, 1863, 1864) of the patella component are created to fit the corresponding surfaces (1852, 1853, 1854) of the femur component, respectively, and, whether normal, varus, or valgus, also take into account the hip-knee-ankle (HKA) alignment of the patient, the prosthesis according to the set of features described above. 47. If the femur component has an offset (1872, 1874) between the distal lateral condyle and the distal medial condyle, the prosthesis according to any of the sets of features described above, wherein the offset (1872, 1874) is replicated within the patella component. 48. The patella component of the knee prosthesis of the present invention, the inner and outer surfaces, are symmetric or asymmetric between the inner and outer compartments, and the front and rear surfaces are symmetric or asymmetric between the front and rear compartments, optionally using a planning algorithm to match the needs of the individual patient, the prosthesis according to the set of features described above. 49. The width and height of each of the inner, outer, front, and rear compartments are specified to be in the range from 8 mm to 30 mm, the value being independent of the thickness of the patella and at least 6 mm or more, the prosthesis according to any of the sets of features described above. 50. Apply curve / surface fitting and smoothing techniques between shapes that interact across adjacent bone compartments and blend the elements of the prosthesis corresponding to the bone compartments to create a hybrid knee prosthesis adapted to the needs of the patient, the prosthesis according to any of the sets of features described above. 51. A knee prosthesis, part or all, designed according to the structural anatomy of an individual patient to recreate the knee joint as if it were natural, the geometry of which is defined by varying independently from each other at the medial femur-tibia joint ~ the lateral femur-tibia joint ~ the femur-patella joint, a knee prosthesis, part or all. A method for creating a partial or total knee prosthesis adapted to the structural anatomy of an individual patient, including a design step of considering the movement behavior of the current or pre-diseased knee joint of the patient and further the hip-knee-ankle (HKA) alignment specific to the patient, and using the input to recreate a knee joint model as if it were natural, and further, the recreated natural knee joint model rather than the pathological knee joint model is used to create a prosthesis that recreates the natural knee joint. 53. A femoral prosthesis for implantation in the femur of a patient's knee, comprising a medial condyle and a lateral condyle, having a bone-facing surface adjacent to at least a part of each condyle of the patient's knee, and an articular surface normally located opposite to each bone-facing surface, each articular surface having a curvature (J curve) normally arranged in a first plane (sagittal plane) and an ML curve normally arranged in second and third planes (frontal plane for the distal condyle and transverse plane for the posterior condyle), each articular surface of the medial condyle and the lateral condyle may have a condyle offset in the second and third planes, which are two condyle parts that are equal or not equal, comprising the trochlear depth, and the medial trochlear ridge and the lateral trochlear ridge, having a bone-facing surface adjacent to at least a part of the trochlea of the patient's knee, and an articular surface normally located opposite to the bone-facing surface, each articular surface having a curvature (J curve) normally arranged in a first plane (sagittal plane) and an ML curve normally arranged in second and third planes (frontal plane and transverse plane), each articular surface of the medial ridge and the lateral ridge may have an offset and trochlear depth in the second and third planes, which is a trochlear part that is equal or not equal, independently, the articular surface orientation of the trochlear part to the distal posterior condyle part of the distal posterior condyle, which can be parallel or inclined (converging or diverging) in at least one of the planes, an ML condyle offset that can be integrated between the medial and lateral articular surfaces of the distal (i.e., distal condyle offset) condyle part and the posterior (i.e., posterior condyle offset) condyle part of the distal posterior condyle, the condyle offset being an equal or different ML condyle offset between the distal condyle part and the posterior condyle part, An ML trochlear offset that can be integrated between the inner articular surface and the outer articular surface of the inner ridge and the outer ridge, the trochlear offset being equal to or different from the condylar offset of the distal posterior condyle, comprising a femoral prosthesis. 54. The prosthesis according to the above set of features, wherein the sagittal J-curve of at least one of the articular surfaces from the distal posterior condyle (inner, outer) or the trochlea (ridge, trochlear depth) is defined by a single, double, or multiple radius or fits a patient-specific J-curve. 55. The prosthesis according to the above set of features, wherein the sagittal J-curve of at least one of the medial and lateral tangent lines is arranged at a fixed or variable distance symmetrically or asymmetrically from the distal posterior condyle to the trochlear J-curve (inner and / or outer ridge, trochlear depth). 56. The prosthesis according to any one of the above sets of features 51 or 52, wherein the sagittal J-curve of at least one of the tangent lines from the distal posterior condyle (inner, outer = narrowing angle) or the trochlea (inner ridge and / or outer ridge, trochlear depth = groove axis in the frontal plane, White side line in the axial plane) is parallel or inclined in at least one of the planes, mainly in the frontal plane and the axial plane. 57. From the viewpoints of sizing (including at least AP sizing), shape (including at least condylar offset, trochlear offset, J-curve, and ML curve), and contour (including at least AP / ML, sizing, narrowing angle, trochlear height, and posterior condyle height), at least one of the articular opposing surfaces of the condylar part and / or the trochlear part has the geometry and dimensions of a joint that corresponds (or closely matches or closely fits) to the knee joint surface of the patient. The prosthesis according to features 51 to 54. 58. The prosthesis according to features 51 to 55, wherein the tangent line connecting the inner and outer most distal positions of the distal bone opposing surface, the tangent line connecting the inner and outer rearmost positions of the bone opposing surface of the posterior condyle, or the tangent line connecting the inner and outer foremost positions of the bone opposing surface of the trochlear part is parallel or inclined between the tangent lines. 59. The prosthesis according to any of the prosthesis feature sets described above, wherein the bone-facing surface is a single straight, smooth, or inclined surface, or two alternating (offset) smooth or inclined surfaces, or alternating (offset) curved surfaces. 60. The prosthesis according to any of the prosthesis feature sets described above, wherein the bone-facing surface is fixed to the bone by cement or cementless fixation. 61. For initial or revision knees (semi-constrained or constrained, hinged), for cement, cementless, or any other type of fixation, for monobloc or modular components, and for each material (Ti, CrCo, ceramic, etc.), the prosthesis corresponding to different systems (PS: Postero-Stabilized, UC: Ultra-Congruent, PCR: Posterior Cruciate Retaining, BCR: Bi-Cruciate Retaining) according to any of the prosthesis feature sets described above. 62. A method for creating a knee prosthesis from a 3D model selected after applying the method, comprising: (a) Analyzing the current and pre-pathological knee behavior of the patient and the 3D HKA alignment of the patient; (b) Optionally selecting an appropriate 3D model from a comprehensive database of 3D models that change knee morphology using a planning algorithm, each 3D model being in a known form and adapted to manufacturing limitations and requirements; (c) Creating the selected 3D model adapted to the 3D structural anatomy of the individual patient and corresponding to an essentially custom knee prosthesis, thereby enabling recreation of the knee joint as if it were natural. A method comprising the above steps. 63. A non-transitory information storage medium having a selection program that instructs a processor to execute any one of the features of a knee prosthesis and the above method to receive an input and generate an output. 64. An encoded selection program that implements a method of instructing a processor to perform steps that assist a user in selecting a 3D knee prosthesis for a particular patient, given the characteristics of the knee prosthesis, the method comprising: (a) parameterizing the knee prosthesis according to clearly defined and independent knee joint compartments; (b) generating a number of knee shapes in the form of 3D knee prosthesis models that replicate the 3D shape asymmetry of a number of individual knee samples, including models that replicate the movement of essentially all patients' knees, by generating a shape that varies the shape parameters (surface and dimensions) of at least one of the compartments, and storing the 3D knee prosthesis models in a database that enables comparison of the asymmetry of the patient's knee with the asymmetry of the 3D knee prosthesis models, associating each model with its shape parameters and asymmetry; (c) learning the patient's pathology and developing pre-pathological knee prosthesis criteria that match the patient's needs, and then optionally using a planning algorithm to search the database that compares the number of knee shapes based on the optimal match of the asymmetry of each model to identify candidate matches; (d) outputting the candidate matches and their attributes to a display device; (e) providing a method for selecting an optimal match from the identified suitable candidate matches; (f) optionally placing an order if the selected knee prosthesis is not in stock. comprising. 65. The medium according to the above feature set, wherein the processor is a computer memory connected to a memory, and the processor accesses a database adapted to store 3D knee prosthesis models or in-stock knee prostheses in response to the program. 66. The medium according to the above feature set, wherein the program causes the processor to respond to inputs and outputs communicated to and from the user.

[0112] Additional features and functionality of the present invention are described in the appended claims and / or the abstract. Those claims and / or the abstract are hereby incorporated by reference in their entirety and considered to be a part of the filed application.

[0113] In the embodiments of the invention described above, various changes and improvements can be made. Specific specific embodiments of the present invention have been disclosed and described, but extensive improvements, changes, and substitutions are contemplated in the above disclosure. The above description includes many specific matters, but is not to be construed as limiting the scope of the invention, but rather as an exemplification of one or other preferred embodiments. In some cases, some features of the present invention are used without using the corresponding other features. Therefore, the above description should be construed broadly and understood as merely an example or illustration, and the spirit and scope of the present invention should be limited only by the claims finally issued in this application.

[0114] Separate Table (Definition) · Definition of knee anatomical position · Definition of knee center · Definition of average knee flexion axis · Knee alignment · Coronal plane or frontal plane · Axial plane or transverse plane (Observation) Comparison with standard (off-the-shelf) knee prostheses and limitations of the present system Description of knee prosthesis Description of the present invention Differences between STD (off-the-shelf) prostheses and our personalized knee prostheses Definition of knee anatomical position FHC(332): Femoral head center KC(330): Knee center TC(334): Talus center (not shown) ME(342): Medial epicondyle LE(344): Lateral epicondyle MDC(352): Medial distal condyle LDC(354): Outer distal condyle MPC(362): Medial posterior condyle LPC(364): Lateral posterior condyle TGH(372): Trochlear groove height TGL(374): Trochlear groove low LT(384): Lateral eminence of the trochlea MT(382): Medial eminence of the trochlea Definition of the knee center KC(330): Upper part of the intercondylar notch TSE(3_): Upper part of the tibial eminence (not shown) MTEA(3_): Middle part of TEA(346) Definition of the average knee flexion axis TEAs(3464): From the upper part of the surgical transccondylar axis (LE(344)) to the groove of ME(342) TEAc(3462): From the upper part of the clinical transccondylar axis (LE(344)) to the upper part of ME(342) CA: Cylinder axis (connecting the centers of the two spherical surfaces of the condyle) EFA: Extension facet axis (connecting the centers of the distal radii of the two condyles) FFA: Flexion facet axis (connecting the centers of the posterior radii of the two condyles) FHA: Femoral helical axis (combining the flexion axis with an axial rotation) · By means of a 4-bar linkage mechanism, the average knee flexion axis can be located at the intersection of the two cruciate ligaments in the sagittal plane, or at the intersection of both the cruciate ligament and the collateral ligament. · By kinematic alignment, BCD and BCP are the instant knee flexion axes. Definition of knee alignment HKA: Limb mechanical axis (= Load-bearing axis) Connect two lines, namely the first line between FHC-KC and the other line between KC-TC When the angle between the two lines is 0 (HKA 180°), the alignment is balanced When the angle between the two lines > 0 (HKA > 180°), the alignment is valgus When the angle between the two lines < 0 (HKA < 180°), the alignment is varus Coronal or frontal plane FAA(326): Femoral anatomical axis (connecting KC(330) to the midshaft of the bone) FMA(336): Femoral mechanical axis (connecting FHC(332) to KC(330)) HKS(338): Angle between FAA(326) and FMA(336) Range is 1° - 10° BCD(356): Bicondylar distal tangent (connecting LDC(354) to MDC(352)) Alpha (α, 358): Angle between FMA(336) and BCD(356) Also referred to as FMA: Femoral mechanical angle (although there is a risk that non - expert readers may confuse FMA (= femoral mechanical axis (336)) with FMA = femoral mechanical angle, an ordinary technician can tell the difference from the context). Also referred to as the midplane: Mechanical medial distal femoral angle Orthogonal or non - orthogonal to FMA(336) Range is 82° - 105° TEA(346): Trans - epicondylar axis, or bicondylar axis Connecting ME(342) to LE(344) TEAs(3464): Surgical trans - epicondylar axis TEAc(3462): Clinical trans - epicondylar axis = Insertion of two collateral ligaments Parallel or non - parallel to BCD(356) Orthogonal or non - orthogonal to FMA(336) DCA(358): Distal condylar angle Angle between TEA(346) and BCD(356) Range is - 5° - 10° SA(376): Sulcus axis (connecting KC(330) to TGH(372)) SA is between FMA(336) and FAA(326) or outside that range Orthogonal or non - orthogonal to TEA(346) and / or BCD(356) Axial plane or transverse plane TL(386): The pulley line that connects LT(382) to MT(384) TEA(346): The supraorbital or bi-orbital axis that connects ME(342) to LE(344) BCP(368): The bi-orbital posterior tangent (connects LPC(364) to MPC(362)) PCA(368): The posterior orbital angle The angle between TEA(346) and BCP(366) The range is -5° to 10° WL(377): The white side line that connects KC(330) to TGL(374) WL is perpendicular or non-perpendicular to TEA and / or BCP ATA(388): The anterior pulley axis The angle between TEA(346) and TL(386) The range is -5° to 10°

Claims

1. 1. A femoral prosthesis for implantation in a femur of a patient's knee, comprising: (a) two condyles, each comprising a medial condyle and a lateral condyle, each having a bone-facing surface abutting at least a portion of each condyle of the patient's knee and an articular surface opposite each bone-facing surface, each articular surface having a curve (J curve) disposed in a first plane (sagittal plane) and an ML curve disposed in a second and third plane (frontal plane and transverse plane at the condyle), each articular surface of the medial condyle and the lateral condyle having a condylar offset in the second and third planes; (b) a trochlear portion comprising a trochlear profundus, a medial trochlear eminence, and a lateral trochlear eminence, the trochlear portion having a bone-facing surface that abuts against at least a portion of the trochlear portion of the patient's knee and an articular surface located opposite the bone-facing surface, each articular surface having a curve (J curve) disposed in a first plane (sagittal plane) and an ML curve disposed in a second and third plane (frontal plane and transverse plane); having (c) the orientation of the articular surfaces of the trochlear portion and the distal and posterior condyles are independent and may be parallel or obliquely oriented (converging or diverging) relative to one another; Femoral artificial joint.

2. The femoral prosthesis of claim 1, wherein the shape radii of the trochlear portion and the two condyles are set independently based on the contact surfaces and bone shapes of the patient's measured femur and tibia, regardless of the patient's measured hip-knee-ankle (HKA) alignment.

3. The femoral prosthesis of claim 1, wherein the contour angles of the anterior and posterior portions of the two condyles are set independently based on the measured contact surfaces and bone shapes of the patient's femur and tibia, regardless of the patient's measured hip-knee-ankle (HKA) alignment.

4. The shape along the first surface of the medial condyle, the shape along the first surface of the lateral condyle, and the shape along the first surface of the trochlear portion are each set independently based on the measured contact surfaces and bone shapes of the patient's femur and tibia, regardless of the patient's measured hip-knee-ankle (HKA) alignment.

5. 2. The femoral joint prosthesis of claim 1, wherein in the two condyles, the articular surfaces of the medial and lateral condyles have equal condylar offsets at the second and third surfaces.

6. The artificial femoral joint according to claim 1 , wherein in the trochlear portion, the articular surfaces of the medial trochlear eminence and the lateral trochlear eminence have an offset and a trochlear depth at the second and third planes.

7. The femoral prosthesis of claim 1, wherein the condyle offset is integrated between the medial and lateral articular surfaces of the distal condyle (i.e., distal condyle offset) and the posterior condyle (i.e., posterior condyle offset), and the condyle offset is equal between the distal condyle offset and the posterior condyle offset.

8. The femoral prosthesis of claim 1 , wherein the trochlear offset is integrated between the medial and lateral articular surfaces of the medial trochlear eminence and the lateral trochlear eminence, and the trochlear offset is the same as the condylar offset.

9. The femoral prosthesis of claim 1, wherein the sagittal J-curve of at least one of the articular surfaces from the distal posterior portion (medial, lateral) of the condyle or the trochlear portion (trochlear eminence, trochlear depth) is defined by a single, double, or multiple radius or fits a patient-specific J-curve.

10. The femoral prosthesis of claim 1, wherein the sagittal J curve of at least one of the medial and lateral tangents is symmetrically positioned at a fixed distance from the distal posterior part of the condyle to the trochlear J curve (medial and / or lateral trochlear eminence, trochlear depth).

11. The femoral prosthesis of claim 1, wherein the sagittal J-curve of at least one of the joint lines from the distal posterior part of the condyle (medial, lateral = narrowing angle) or the trochlea (medial trochlear eminence and / or lateral trochlear eminence, trochlear depth = groove axis in the frontal plane, Whiteside's line in the axial plane) is obliquely oriented in at least one of the planes, primarily the frontal plane and the axial plane.

12. 2. The femoral prosthesis of claim 1, wherein at least one of the articular surfaces of the condylar and / or trochlear portions has a joint geometry and dimensions that correspond (or closely match or closely fit) to the patient's knee joint surface in terms of measurements (including at least AP measurements), shape (including at least condylar and trochlear offsets, J curves, and ML curves), and contours (including at least AP / ML measurements, narrowing angle, trochlear height, posterior condylar height).

13. The femoral artificial joint of claim 1, wherein a tangent line connecting the inner and outer most distal positions of the bone-facing surface of the distal part of the condyle, a tangent line connecting the inner and outer most rear positions of the bone-facing surface of the posterior part of the condyle, or a tangent line connecting the inner and outer most anterior positions of the bone-facing surface of the trochlear part are parallel to or inclined to each other.

14. 2. The femoral joint prosthesis of claim 1, wherein the bone-facing surface is a single straight smooth or beveled surface, or two alternating (offset) smooth or beveled surfaces, or alternating (offset) curved surfaces.

15. The femoral joint prosthesis of claim 1 , wherein the bone-facing surface is fixed to the bone by cementation.

16. 2. The femoral joint prosthesis according to claim 1, characterized in that for primary or revision knees (semi-constrained or constrained, hinged), for cemented fixation, for monobloc or modular components, and for materials selected from one of the group of materials typically consisting of Ti, CrCo, ceramics, the prosthesis corresponds to different systems selected from one of the group of systems consisting of PS: Posterior Stabilized, UC: Ultra-Congruent, PCR: Posterior Cruciate Retaining, BCR: Bi-Cruciate Retaining.

17. A partial or total knee prosthesis comprising a femoral prosthesis according to any one of claims 1 to 16.

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