WO2021105837A1

WO2021105837A1 - Direct knee alignment system (d-kas), device and method thereof

Info

Publication number: WO2021105837A1
Application number: PCT/IB2020/060993
Authority: WO
Inventors: Cristián Andrés BLANCO MORENO
Original assignee: Blanco Moreno Cristian Andres
Priority date: 2019-11-27
Filing date: 2020-11-21
Publication date: 2021-06-03
Also published as: CL2022001331A1

Abstract

Embodiments of the present invention are directed to a system, device, and method for direct knee alignment. The system may comprise a direct knee alignment device; an installation stage for the direct knee alignment device; and a removal stage for the direct knee alignment device.

Description

DIRECT KNEE ALIGNMENT SYSTEM (D-KAS), DEVICE AND METHOD

THEREOF

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of the following U.S. provisional patent application Ser. Nos. 62/941, 171 and 63/030,866 which are incorporated in their entirety herein by this reference.

TECHNICAL FIELD

[0002] The disclosure relates generally to the field of surgery and more specifically to new and useful systems and methods for knee alignment in the field of medicine.

BACKGROUND

[0003] Knee replacement surgery is a common bone surgery procedure that has existed for more than 40 years, since initial development and implementation.

[0004] The main objective of knee replacement surgery includes replacing the damaged articular surfaces from distal femur bone, proximal tibia bone, and from the knee cap (e.g., as necessary in relation to the knee cap, etc.). The prosthetic solution involves performing a surgical technique that allows a functional knee, with mobility but also stable at all levels across planes and with a properly aligned axis.

[0005] The objective sought in terms of the alignment of a surgically intervened limb is to find an axis that is closest to the neutral; in the case of the knee, a neutral axis can be established from the center of the femoral head to the center of ankle joint, through the center of the knee. In a regular knee prosthetic surgery, this means that the distal femoral cut must be perpendicular to this axis (neutral axis); likewise, the tibial cut must be located and performed perpendicular to this axis and therefore must be, at least in theory, parallel to the femoral cut. The same applies with respect to the new joint surface of the distal femur and proximal tibia. [0006] Despite the theory, the practice of medicine has shown that at least a relevant percentage of knee prosthesis are unable to accomplish the ideal objective, regarding knee alignment. In addition, during the last 10 years of research in the field of medicine, it has been shown that a deviation regarding the neutral axis, can affect durability of the knee prosthesis, depending of the type of deviation (e.g., varus or valgus deviation), where a varus deviation between 3 and 6 degree but not beyond these limits, is better tolerated than a valgus deviation. In addition, a further deviation of any of these types from neutral axis has been associated with poor clinical performance results in terms of knee functionality, especially regarding pain and issues for the patients like external appearance of the extremity.

[0007] An alternative for aforementioned issues regarding knee surgical procedure, has been to incorporate advanced technology and robotic assistance, in order to improve performance and better clinical results after surgery. The main issue regarding such solutions, however, is extremely high cost and therefore, difficulty to scale and expand massively across hospitals and medical centers, with the main use cases almost exclusively reserved for those medical centers specialized on prosthetic surgery procedures, that can afford the extra cost associated with corresponding demand of affected patients.

[0008] More recently, the concept of neutral alignment has been challenged moving instead to a personalized alignment for each knee and corresponding patient. The support behind this new approach is related with a relevant group of patients dissatisfied symptomatically and functionally with final results of their knee prostheses, that can receive benefits of a more personalized surgical procedure for knee prosthesis, according to their own bone and ligament anatomy. Nevertheless, this last situation is a completely new concept and it is in a very early stage of discussion, without any valid results yet. Traditionally, the ideal knee surgical procedure is to align a knee as much aligned as possible with the neutral axis on the frontal plane.

[0009] In general terms of regular surgical procedure for knee prosthesis alignment, comprises: i) frontal alignment, ii) femoral cut, iii) tibial cut; wherein frontal alignment is performed by prosthesis alignment at frontal plane and limb in extension, and the frontal plane is defined by distal femoral cut and tibial cut, and wherein both cuts are made with the intention to have a correct aligned limb with respect to neutral axis, and with both surface joint cuts made in parallel, and a horizontal joint line to the ground.

[0010] Femoral cut is generally made considering mechanical femoral axis, wherein angulation may vary 5-7 degrees between anatomic and mechanical femoral axis, without considering tibia bone. This cutting angle is defined with pre-established guides on the regular technique, and these cutting guides can be from two types: a) extramedullary or b) intramedullary. Except for very special situation and regarding very altered femoral anatomy, intramedullary guidance is commonly used because are more effective and provide improved precision than extramedullary for many reasons, as follows: axial femoral rotation on surgery table, difficulties to look for and found anatomic reference points under surgical drapings during surgery, etc. [0011] Finally, the tibial cut is the one present the greatest variability on its performance, regarding localization and depth of the cut, wherein surgical expertise will play a key role to reduce this issue. Nevertheless, there is still an unsatisfied need for having a more efficient, reproducible and easy system to perform this cut in a proper manner, as the key for the final alignment of the limb. There are also extramedullary and intramedullary guides to perform tibial cut, but in this case anatomic issues are easiest to find than femoral bone by using an extramedullary cutting guide, where this type of guide is normally preferred, instead intramedullary ones, also regarding tibial anatomy.

[0012] In addition, since the origins of the knee surgery, regular technique involves defining and performing this cut with the knee in flexion, bringing the main issue regarding neutral axis alignment defined in extension, as previously mentioned. It’s already known that to perform the cut in flexion relax the posterior neurovascular structures and decrease the risk of a cutting lesion from the use of a cutting saw.

[0013] So far, femoral and tibial cuts are performed in a separated manner, independently and without any influence between each other in order to achieve a neutral axis on the full limb extension, despite this axis is equally dependent on each cut.

BRIEF DESCRIPTION OF THE DRAWINGS [0014] FIGURE 1 - A specific example of a view of components of an embodiment of the knee alignment system, including: Metal piece like knee prosthesis, two metal bars, a pin block and a metal guide for tibial cut.

[0015] FIGURE 2 - A specific example of a view of an embodiment of the system installed as part of a (simulation of) a usual surgical procedure for knee alignment.

[0016] FIGURE 3 - A specific example of an upper view of an embodiment of the system installed, ready for defining the second cut (tibial) based on a first cut (femoral) already made.

[0017] FIGURES 4 to 10 - Specific examples of the system, mounted on the knee and tibial bone, such as according to portions of an embodiment of a method including mounting within surgery including an adjustment small piece for mechanically blocking the bars and avoiding pieces moving after being settled in a fixed position.

[0018] FIGURES 9 to 10 - Specific examples of the system, mounted on the knee and tibial bone, such as according to portions of an embodiment of a method including mounting within surgery. [0019] FIGURES 11 to 14 - Specific examples of a variation of the device of the alignment system, including the representation of each part of the device and a mounted on the knee and tibial bone, according to an embodiment of a method including mounting within surgery.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

[0020] The following description of the embodiments (e.g., including variations of embodiments, examples of embodiments, specific examples of embodiments, other suitable variants, etc.) is not intended to be limited to these embodiments, but rather to enable any person skilled in the art to make and use.

[0021] If it would be possible to define the tibial cut with the limb in extended position considering the final alignment (in extension) instead and after that, perform the cut in flexion according method previously described, we will have a more logical and close-to-natural situation, and an improved surgery technique to be performed.

[0022] Here we described an improved surgical technique, including an improved methodology and new extramedullary cutting guides prototype for the tibial cut, wherein the tibial cut is considered the key cut to define the final axis for the limb, and wherein the tibial cut is pre- defined in extension, and cut is performed in flexion of the limb, unifying the best of both worlds in relation with regular technique for knee surgery: defining the tibial cut with extramedullary guides in extension according neutral axis, but also providing a cut as safe as usual because is performed in flexion as regular technique, without significantly modifying the regular knee surgical procedure at any operating room, making this improved system compatible with any hospital and medical center with standard condition for a regular knee surgical procedure.

[0023] Embodiments can include a system, method and a (set of) prototypes that allows improvement in the alignment of a knee, in an easy way and compatible with a regular surgical procedure for knee alignment, and with any standard prosthetic system currently available, from different vendors. Aforementioned attributes make current technology an integrated system, available for us at any hospital and medical center, within any operating room, with no more than 10-15 additional minutes, reducing cost and improving the results of a conventional knee alignment surgery.

[0024] In one embodiment, the system allows an efficient manner to define a tibial cutting guide, in an extended limb properly aligned with neutral axis, wherein the alignment is perform in extension along with tibial cut definition, and delaying cut afterwards in flexion, wherein the tibial cut is safer according usual surgical procedure.

[0025] In one embodiment, the disclosed system allows to define the tibial cut based on femoral cuts, and in alignment with neutral axis in an integrated procedure, wherein the final alignment is taken into account prior to the tibial cut, avoiding alignment errors by performing tibial cut in a separated way, without considering neutral axis and femoral cut in full extension position for the limb. Embodiments can allow a decrease in inadmissible errors that involves repeat tibial cut after performed, in order to correct final alignment of the limb, that increase loss of bone stock, surgery time and any potential issues associated with making new errors.

[0026] In one embodiment, the disclosed system Integrates both femoral and tibial cuts, making a second cut (tibial cut) directly dependent on the first (set of) cut(s) for distal femur performed with a intramedullary guide ad hoc (the most efficient and reliable), wherein distal femur cut defines how should be made the tibial cut, in order to obtain at the end a tibial and femoral cut both parallel each other and parallel to the ground with the limb in extension, and at the same time with a neutral axis.

[0027] In one embodiment, the tibial cut is defined and checked previously to the cut is made, theoretically decreasing the chance and the need to perform more than one tibial cut (a second, a third or even a fourth one) by mistake, reducing any potential surgery complications because any additional cut and the time of the procedure, just because current proposed technology herein acts “before the error”, and wherein the tibial cut once defined can be performed in a safe manner in a flexion position, according to usual technique of any surgeon and any prosthesis system.

[0028] In certain embodiments, the tibial cut in the sagittal plane, similar to any modem system usually and currently available, can be modified by bringing the tibia closer or further from the alignment system; wherein this feature is not lost unlike other known systems where the relationship femur-tibia are established in a more rigid way.

[0029] In one embodiment, is universal for all prosthesis system used into any usual knee alignment surgery, wherein the system depends first only from initial distal and anterior femoral cuts, that are universal and compatible with any knee prosthesis system procedure, and secondly for a tibial cut made afterwards, as in any regular knee surgery procedure . This means, that certain embodiments can be embedded into any standard surgery procedure for knee alignment, and by using any prosthetic system currently available, wherein the certain embodiments include a metal piece that look like a standard knee prosthetic piece with coupling for the distal and anterior femoral cut, and wherein this metal piece can be removed at the end of the current disclosed methodology, and replaced with the definitive prosthetic piece without keeping the final alignment of the knee, ankle and hips with neutral axis in extension of the limb.

[0030] In certain embodiments, the implementation of knee alignment system does not require any external system or high cost additional system to the surgical field, wherein the surgery is performed in a usual and known environment by surgical team and support team at the operation room.

[0031] In certain embodiments, no large or special operation room is required for use of herein disclosed technology; nor specially trained staff is required either and no expensive and bulky storage of technological equipment is required.

[0032] In certain embodiments, the herein proposed technology is timely effective because it only adds 5-10 extra minutes to a usual surgical technique for knee alignment procedure, facilitating the use of the technology without increase cost associated with infrastructure use, wherein each component of embodiments of the system can be sterilized and complying standard regulation of the surgical field.

[0033] Femoral or tibial rotation can alter to some extent the correct definition of the axis of the entire limb.

[0034] The plane of rotation of the femur in the coronal plane can be defined by the anterior femoral cut in the traditional and usual way of surgical techniques.

[0035] The rotation of the tibia in relation to the femur cannot be managed with the traditional method using the extramedullary cutting guide that connects the proximal tibia to the ankle. In specific examples, apiece fitted to the ipsilateral ankle and with the knee in flexion can be used. This has no relation to the coronal plane of the distal femur already performed or to be performed.

[0036] In embodiments, the system can include a system that relates the rotation of the tibia to the coronal plane (femoral rotation at the knee level). In a specific example, the system can include one or more components that allow it to keep aligned the long bar within the knee and ankle axis.

[0037] The problem of femoral and tibial rotation as previously mentioned may alter to some extent the correct definition of the axis of the entire limb.

[0038] The problem of the femoral and tibial rotation is managed by incorporating a system that relates the anterior femoral cut already made with the rotation of the tibia with the limb in extension and can include any one or more of: [0039] The expansion of the femoral part can include an indelible laser mark exactly in its center by anterior and distal proximal, defining a plane perpendicular to the rotational plane to the distal femur.

[0040] The one or more bars can be marked in their center in the same way defining a plane that divides it into two equal halves.

[0041] Both bars and determined by the laser mark plane can include a free end section

(e.g., not threaded) of 1.5 cm and/or other suitable dimensions.

[0042] Y -shaped metal part for the ankle whose long end can be adjusted to the section of the bars at its end.

[0043] The bars so marked can be passed through the hole of the femoral piece and left thigh, bars and femoral piece, exactly according to the laser marks.

[0044] This can be fixed with an adjustment screw in the femoral part.

[0045] This can determine that the plane of the distal section of both bars is exactly perpendicular to the anterior femoral plane.

[0046] Thus, the Y -piece inserted in the punch of the bar and resting on the ankle will better determine the rotation of the tibia in relation to the femur.

[0047] The described components are preferably used before defining the tibial cut.

[0048] In specific examples, the assembled guide bar or the bars are removed separately together with the Y -guide, then the pin block for the tibial cutting guide, the metal part of the femur is removed and any suitable surgical techniques can be continued.

[0049] Embodiments can include one or more knee alignment systems that can be used in at least one or more of the followings specific examples of stages:

[0050] 1. Installation stage, wherein the installation of each part of the system can include one or more of:

[0051] A metal piece with the distal and anterior aspect of a conventional knee prosthesis in its femoral component, wherein the width of the piece correspond to the usual resection in the usual femoral cuts, about 9mm (but can alternatively include any suitable dimensions), equivalent to the section usually replaced by the knee prosthesis, wherein this metal piece adapts to the anterior and distal femur cut previously performed on the axis defined by the surgeon, not by the piece; wherein the femoral metal piece has an anterior expansion that is exactly parallel to the distal cut, and perpendicular to the anterior cut , therefore it is not different from the angle of the distal femoral cut and is also right in the center of the knee; and wherein the anterior metal expansion has a hole aligned exactly perpendicular to it and therefore perpendicular to the distal cut. [0052] Two metal bars of at least 35 cm each than can be precisely assembled to each other to obtain a final bar of at least 70 cm (but can alternatively include any suitable dimensions), wherein these bars slide through the opening of the anterior expansion of the femoral part that is located in the center of the knee; and wherein these are the bars that are used to establish the mechanical axis of the limb from the center of the femoral head to the center of the ankle through the center of the knee aforementioned.

[0053] A Pin block for the tibial cut definition guide, wherein this pin block is a metal block of at least about 3x4x1.5 cm (but can alternatively include any suitable dimensions) with at least a central hole that slides through the bars and at least an entry on each side that allows adjustment of the tibial cut guide and thus define the position of the tibial cut.

[0054] The guide for defining the tibial cut including a set of several holes in it that allows to adjust to the bar to define the depth and angulation of the tibial cut, wherein this guide for defining the tibial cut adjusts to the bar that is perfectly aligned with the neutral [0055] mechanical axis of the limb, and that is also perpendicular to the femoral cut, a tibial cut that is parallel to the femoral cut and horizontal to the ground is expected , at least regarding frontal plane; and wherein sagittal plane (tibial slope) can be adjusted with the change of position of the tibia, closer or further from the bar where the pin block of the tibial cut definition guide slides, with the “pins” that define the position of the tibial cut are properly installed prior actually realizing the final cut.

[0056] 2. Removal Stage: Removed the assembled guide bar or bars separately, then the pin block for the tibial cut guide, the metal femur piece is removed, and the knee surgery can continue with the usual technique known by the surgeon.

EXEMPLARY EMBODIMENTS OF THE INVENTION

[0057] The following exemplary embodiments may be utilized in combination with one another or individually. Further, as will be appreciated by one skilled in the art, different portions of the various exemplary embodiments may be interchanged or utilized in another exemplary embodiment.

[0058] Exemplary embodiment 1 : As a specific example of the present invention in the context of a surgical technique or surgical procedure, including one or more components of embodiments of the system previously described, as follows:

[0059] 1. Preparation of usual operating room and equipment, for a knee alignment surgical procedure.

[0060] 2. Positioning of the patient according usual procedure. [0061] 3. Prior to performing the surgical field and with the help of the fluoroscope, the femoral head and its center are identified on the side to be operated and marked on the skin with an electrode button for electrocardiogram monitoring.

[0062] 4. Preparation of regular sterile field, except that the access of the axle bars to the hip and the possibility of palpation of the electrode that defines the position of the center of the hip should be considered, in order to be able to properly control the axis of the limb during surgery.

[0063] 5. Performing usual incision.

[0064] 6. Performing femoral cut according to regular procedure, wherein preferably only perform the distal and anterior femoral cut

[0065] 7. Install the femoral piece of the invention pinned to the distal femur.

[0066] 8. Extend the limb, including the device of the invention with femoral piece installed and pinned.

[0067] 9. Install the bar (or bars) for alignment of the invention, by using central hole of the femoral piece.

[0068] 10. Move the limb (tibial bone) until the ax of the complete limb is in a neutral axis aligning center of the hip - center of the knee - center of the ankle. A confirmation by using fluoroscope can be used also if needed.

[0069] 11. Establish the rotation of the tibia in relation to the anterior femoral cut with the bars and the Y -piece as an aid. Bars aligned in their laser marks with the femoral part. Thus, the Y guide for the ankle can pass through a section perpendicular to the anterior femoral cut and so the tibia can be aligned parallel to that plane using the maleolos or other preferred anatomical reference (Second metatarsal) as a reference. If desired, this can be confirmed fluoroscopically as well.

[0070] 12. Place the pin block of the tibial cutting guide in the alignment bar

[0071] 13. Adjust the tibial cut guide to the block and then adjusting the depth of the cut and keeping the previously defined axis pass the pins that will mark or define the tibial cut. [0072] 14. Sequential removal of system parts as previously described (bar-block-tibial cutting guide femoral part- Y-piece).

[0073] 15. Repositioning the knee in flexion, preparing the limb for the tibial cut. 16.

Continue with the usual technique used by the surgeon for each prosthetic model, including performing tibial cut.

[0074] Exemplary embodiment 2: As an example of another embodiment of the invention, can include followings steps: [0075] I. Femoral Piece:

[0076] a. In the part of the femoral piece that represents a prosthetic implant, as seen in the image (FIGURE 11), the depth of the two distal bars was shortened to allow adjustment to the measurement of all the knees, including the smaller ones in anteroposterior diameter. The volume of the proximal piece was decreased to make it more easily manipulated.

[0077] b. The anteriorly projecting bar receiving the alignment guide slid distally to a position even closer to the center of the knee.

[0078] c. The same previous bar was extended to have space for three other holes that can receive the alignment guide. This in case of patients with more voluminous thighs allows to have space to raise the alignment guide and thus confirm the required axes, first the mechanical axis of the femur and then the frontal axis of the entire limb.

[0079] The wrench (or two) is held to fix the alignment guide.

[0080] The linear laser mark of the complete bar is maintained that fixes the axis perpendicular to the distal femoral cut, as described in Figure 11A to 11C.

[0081] II. Tibial cutting guide system:

[0082] Initially this guide was a single piece to slide through the alignment guide and another piece that was the guide for the tibial cut. This system requires the adjustment of these two pieces and makes it difficult to establish the final position of the system and then perform the tibial cut definitively and safely.

[0083] It was decided to make a right and a left piece to adapt to the new sliding system seen in the image.

[0084] This system includes in one piece the proximal-distal slide and also the slide to bring the tibial cutting guide closer to the anteromedial aspect of the tibia as seen in the image (Integrated).

[0085] This prevents rotation of the tibial cutting guide in the axial plane and does not allow changes in the sagittal axis (tibial slope).

[0086] Always keeping parallel to the distal cut of the femur.

[0087] The cutting guide system is described in Figure 12.

[0088] III. Alignment guide:

[0089] a. This guide was made thinner for the new integrated tibial cutting system.

[0090] The guide maintains the laser mark to control and maintain the perpendicular relationship of the tibial cut to this guide and also for the use of the Y guide of the tibial rotation, as seen in the image. [0091] b. Graduated marks in millimeters are incorporated at both ends (screwable) of the guide.

[0092] Once fixed to the femoral piece (Bar) with the corresponding key, these marks serve to determine the depth of the tibial cut by sliding the integrated cutting system the required number of millimeters.

[0093] c. As mentioned, this guide can be placed in the upper holes of the femoral piece in the case of more bulky thighs, maintaining the relationship perpendicular to the distal femoral cut.

[0094] As an example of the alignment guide is shown below, in Figures 13A to 13C.

Finally an example of assembly of the complete system is displayed in Figure 14.

[0095] In variations, any suitable portions and/or combination of surgical technique processes described herein can be performed in any suitable order.

[0096] In specific examples, the use of the system and its withdrawal should not take more than 5 to 10 additional surgical minutes to any usual surgery.

[0097] Exemplary embodiment 3 : A system for correct and align a knee within a surgical procedure directly and without a robotic system or device, that allows the use of the distal femoral cut as starting point reference to get the tibial cut right and comprising the following components: A direct knee alignment device, An Installation stage for the device, and A removal stage for the device.

[0098] Exemplary embodiment 4: Any of the previous exemplary embodiments further comprising, wherein the direct knee alignment device can comprise: a femoral piece, wherein the femoral piece comprise a metal piece with the distal and anterior aspect of a conventional knee prosthesis in its femoral component (FIGURE 1), a set of tibial cutting guides pieces, including at least a left and right cutting guides pieces, a set of alignment rods, including at least two alignment rods, and an Y-shaped piece.

[0099] Exemplary embodiment 5: Any of the previous exemplary embodiments further comprising, wherein the femoral piece can mimic the femoral implants, can be placed towards at the center of the notch and can include holes perpendicular-plane to the distal cut.

[00100] Exemplary embodiment 6: Any of the previous exemplary embodiments further comprising, wherein the set of tibial pieces can be disposed exactly perpendicular to the rod and therefore parallel to the distal femoral cut, including holes to pin it down to the bone, and also includes a screw mechanism, to slide up and down the tibial cutting guide, and additionally knob to lock the piece to the alignment rod.

[00101] Exemplary embodiment 7: Any of the previous exemplary embodiments further comprising, wherein the set of alignment rods can also limb alignment/tibial rotation control and depth of the cut and slope, wherein the two rods: are connected at proximal ends, slots at each distal end accept for Y-shaped piece, includes a laser mark with a midline in continuity with the slots and graduated (mm) to define the depth of the cut.

[00102] Exemplary embodiment 8: Any of the previous exemplary embodiments further comprising, wherein the Y-shaped piece includes a laser marks of the femoral piece/rods and the slot should be perpendicular to the distal femoral cut surface to control the rotation of the tibia, and wherein the alignment of the limb can be controlled by centering the Y-shaped piece in the ankle/2nd toe. [00103] Exemplary embodiment 9: Any of the previous exemplary embodiments further comprising, wherein the Installation stage comprises installation of each part of the system as follows, including: the femoral piece, wherein the width of the femoral piece correspond to the usual resection in the usual femoral cuts, about 9mm (but can alternatively include any suitable dimensions), equivalent to the section usually replaced by the knee prosthesis, wherein the femoral piece adapts to the anterior and distal femur cut previously performed on the axis defined by the surgeon, not by the piece; wherein the femoral piece has an anterior expansion that is exactly parallel to the distal cut, and perpendicular to the anterior cut, therefore it is not different from the angle of the distal femoral cut and is also right in the center of the knee; and wherein the anterior metal expansion has a hole aligned exactly perpendicular to it and therefore perpendicular to the distal cut. Two metal bars of at least 35 cm each than can be precisely assembled to each other to obtain a final bar of at least 70 cm (but can alternatively include any suitable dimensions), wherein these bars slide through the opening of the anterior expansion of the femoral part that is located in the center of the knee; and wherein these are the bars that are used to establish the mechanical axis of the limb from the center of the femoral head to the center of the ankle through the center of the knee aforementioned. A Pin block for the tibial cut definition guide, wherein this pin block is a metal block of at least about 3x4x1.5 cm (but can alternatively include any suitable dimensions) with at least a central hole that slides through the bars and at least an entry on each side that allows adjustment of the tibial cut guide and thus define the position of the tibial cut. The tibial cutting guides, wherein the guide for defining the tibial cut including a set of several holes in it that allows to adjust to the bar to define the depth and angulation of the tibial cut, wherein this guide for defining the tibial cut adjusts to the bar that is perfectly aligned with the neutral mechanical axis of the limb, and that is also perpendicular to the femoral cut, a tibial cut that is parallel to the femoral cut and horizontal to the ground is expected , at least regarding frontal plane; and wherein sagittal plane (tibial slope) can be adjusted with the change of position of the tibia, closer or further from the bar where the pin block of the tibial cut definition guide slides, with the “pins” that define the position of the tibial cut are properly installed prior actually realizing the final cut.

[00104] Exemplary embodiment 10: Any of the previous exemplary embodiments further comprising, wherein the removal Stage includes: Remove the assembled guide bar or bars separately, then the pin block for the tibial cut guide, the metal femur piece is removed, and the knee surgery can continue with the usual technique known by the surgeon. [00105] Exemplary embodiment 11: Any of the previous exemplary embodiments further comprising, wherein the system allows an efficient manner to define a tibial cutting guide, in an extended limb properly aligned with neutral axis, wherein the alignment is perform in extension along with tibial cut definition, and delaying cut afterwards in flexion, wherein the tibial cut is safer according usual surgical procedure.

[00106] Exemplary embodiment 12: Any of the previous exemplary embodiments further comprising, wherein the disclosed system allows to define the tibial cut based on femoral cuts, and in alignment with neutral axis in an integrated procedure, wherein the final alignment is taken into account prior to the tibial cut, avoiding alignment errors by performing tibial cut in a separated way, without considering neutral axis and femoral cut in full extension position for the limb.

[00107] Exemplary embodiment 13: Any of the previous exemplary embodiments further comprising, wherein the system allows a decrease in inadmissible errors that involves repeat tibial cut after performed, in order to correct final alignment of the limb, that increases loss of bone stock, surgery time and any potential issues associated with making new errors.

[00108] Exemplary embodiment 14: Any of the previous exemplary embodiments further comprising, wherein the disclosed system integrates both femoral and tibial cuts, making a second cut (tibial cut) directly dependent on the first (set of) cut(s) for distal femur performed with a intramedullary guide ad hoc (the most efficient and reliable), wherein distal femur cut defines how should be made the tibial cut, in order to obtain at the end a tibial and femoral cut both parallel each other and parallel to the ground with the limb in extension, and at the same time with a neutral axis.

[00109] Exemplary embodiment 15: Any of the previous exemplary embodiments further comprising, wherein the tibial cut is defined and checked previously to the cut is made, decreasing the chance and the need to perform any additional tibial cut by mistake, reducing any potential surgery complications because any additional cut and the time of the procedure, because disclosed technology allows to the surgeon to acts preventively, and wherein the tibial cut once defined can be performed in a safe manner in a flexion position, according to usual technique of any surgeon and any prosthesis system.

[00110] Exemplary embodiment 16: Any of the previous exemplary embodiments further comprising, wherein the tibial cut in the sagittal plane can be modified by bringing the tibia closer or further from the alignment system.

[00111] Exemplary embodiment 17: Any of the previous exemplary embodiments further comprising, wherein the system depends first only from initial distal and anterior femoral cuts, that are universal and compatible with any knee prosthesis system procedure, and secondly for a tibial cut made afterwards, as in any regular knee surgery procedure.

[00112] Exemplary embodiment 18: Any of the previous exemplary embodiments further comprising, wherein the system can include a sub-system that relates the rotation of the tibia to the coronal plane (femoral rotation at the knee level), and wherein the sub-system can include one or more components that allow it to keep aligned the long bar within the knee and ankle axis.

[00113] Exemplary embodiment 19: Any of the previous exemplary embodiments further comprising, wherein the implementation of currently disclosed knee alignment system does not require any external system or high cost additional system to the surgical field, and wherein the surgery is performed in a usual and known environment by surgical team and support team at the operation room, with no large or special operation room, nor specially trained staff is required and no expensive and bulky storage of technological equipment is required either. [00114] Exemplary embodiment 20: Any of the previous exemplary embodiments further comprising, wherein the amount of time needed for application of the system within a surgery, is in the range of 5 to 10 minutes long.

[00115] Exemplary embodiment 21: Any of the previous exemplary embodiments further comprising, wherein the system allows improvement in the alignment of a knee, in an easy way, compatible with any regular surgical procedure for knee alignment, and also compatible with any standard prosthetic system currently available.

[00116] Exemplary embodiment 22: Any of the previous exemplary embodiments further comprising, wherein the system is compatible with any hospital and medical center, with any operating room and/or any facilities available for surgery.

[00117] Exemplary embodiment 23: Any of the previous exemplary embodiments further comprising, wherein the system allows reducing cost and improving the results of a conventional knee alignment surgery, with no need of a highly complex infrastructure.

[00118] Exemplary embodiment 24: A method for the application of any of the previous exemplary embodiments, including one or more components of embodiments of the system previously described, as follows: Preparation of usual operating room and equipment, for a knee alignment surgical procedure; Positioning of the patient according to usual procedure; Prior to performing the surgical field and with the help of the fluoroscope, the femoral head and its center are identified on the side to be operated and marked on the skin with an electrode button for electrocardiogram monitoring; Preparation of regular sterile field, except that the access of the axle bars to the hip and the possibility of palpation of the electrode that defines the position of the center of the hip should be considered, in order to be able to properly control the axis of the limb during surgery; Performing usual incision; Performing femoral cut according to regular procedure, wherein preferably only perform the distal and anterior femoral cut; Install the femoral piece of the invention pinned to the distal femur. Extend the limb, including the device of the invention with femoral piece installed and pinned. Install the bar (or bars) for alignment of the invention, by using the central hole of the femoral piece. Move the limb (tibial bone) until the ax of the complete limb is in a neutral axis aligning center of the hip - center of the knee - center of the ankle, wherein a confirmation by using a fluoroscope, can also be used if needed. Establish the rotation of the tibia in relation to the anterior femoral cut with the bars and the Y-piece as an aid. Bars aligned in their laser marks with the femoral part. Thus, the Y guide for the ankle can pass through a section perpendicular to the anterior femoral cut and so the tibia can be aligned parallel to that plane using the maleolos or other preferred anatomical reference (Second metatarsal) as a reference. If desired, this can be confirmed fluoroscopically as well. Place the pin block of the tibial cutting guide in the alignment bar. Adjust the tibial cut guide to the block and then adjusting the depth of the cut and keeping the previously defined axis pass the pins that will mark or define the tibial cut. Sequential removal of system parts as previously described (bar-block-tibial cutting guide femoral part- Y-piece). Repositioning the knee in flexion, preparing the limb for the tibial cut. 16. Continue with the usual technique used by the surgeon for each prosthetic model, including performing tibial cut.

[00119] Exemplary embodiment 25: Any of the previous exemplary embodiments further comprising, wherein the method can also include followings steps: Femoral Piece Step: wherein the part of the femoral piece that represents a prosthetic implant, as seen in FIGURE 11 (11 A to 11C), the depth of the two distal bars was shortened to allow adjustment to the measurement of all the knees, including the smaller ones in anteroposterior diameter, and additionally, the volume of the proximal piece was decreased to make it more easily manipulated, wherein the anteriorly projecting bar receiving the alignment guide slide distally to a position even closer to the center of the knee, wherein the same previous bar was extended to have space for three other holes that can receive the alignment guide, and wherein, in case of patients with more voluminous thighs allows to have space to raise the alignment guide and thus confirm the required axes, first the mechanical axis of the femur and then the frontal axis of the entire limb, wherein at least one wrench (or two) is held to fix the alignment guide, and wherein the linear laser mark of the complete bar is maintained that fixes the axis perpendicular to the distal femoral cut, as described in Figure 11A to 11C. Tibial cutting guide system step, includes: A right and a left piece to adapt to the new sliding system seen in FIGURE 12. wherein current system also includes in one piece the proximal-distal slide and also the slide to bring the tibial cutting guide closer to the anteromedial aspect of the tibia as seen in the image (FIGURE 12), wherein the current system prevents rotation of the tibial cutting guide in the axial plane and does not allow changes in the sagittal axis (tibial slope), and wherein always keeping parallel to the distal cut of the femur. Alignment guide step: wherein alignment guide was made thinner for the new integrated tibial cutting system, wherein the alignment guide maintains the laser mark to control and maintain the perpendicular relationship of the tibial cut to this guide and also for the use of the Y guide of the tibial rotation, as seen in the FIGURES 13 A to 13C, wherein graduated marks in millimeters are incorporated at both ends (screwable) of the alignment guide, wherein once fixed to the femoral piece (Bar) with the corresponding key, these marks serve to determine the depth of the tibial cut by sliding the integrated cutting system the required number of millimeters, and wherein the alignment guide can be placed in the upper holes of the femoral piece in the case of more bulky thighs, maintaining the relationship perpendicular to the distal femoral cut.

[00120] Exemplary embodiment 26: A device of any of the previous exemplary embodiments comprising, a device for correct and align a knee within a surgical procedure directly and without a robotic system or device, that allows the use of the distal femoral cut as starting point reference to get the tibial cut right and comprising the following components: a femoral piece, wherein the femoral piece comprise a metal piece with the distal and anterior aspect of a conventional knee prosthesis in its femoral component (FIGURE 1), a set of tibial cutting guides pieces, including at least a left and right cutting guides pieces, a set of alignment rods, including at least two alignment rods, and an Y-shaped piece.

[00121] Exemplary embodiment 27: Any of the previous exemplary embodiments further comprising, wherein the femoral piece can mimic the femoral implants, can be placed towards at the center of the notch and can include holes perpendicular-plane to the distal cut.

[00122] Exemplary embodiment 28: Any of the previous exemplary embodiments further comprising, wherein the set of tibial pieces can be disposed exactly perpendicular to the rod and therefore parallel to the distal femoral cut, including holes to pin it down to the bone, and also includes a screw mechanism, to slide up and down the tibial cutting guide, and additionally knob to lock the piece to the alignment rod.

[00123] Exemplary embodiment 29: Any of the previous exemplary embodiments further comprising, wherein the set of alignment rods can also limb alignment/tibial rotation control and depth of the cut and slope, wherein the two rods: are connected at proximal ends, slots at each distal end accept for Y-shaped piece, includes a laser mark with a midline in continuity with the slots and graduated (mm) to define the depth of the cut.

[00124] Exemplary embodiment 30: Any of the previous exemplary embodiments further comprising, wherein the Y-shaped piece includes a laser marks of the femoral piece/rods and the slot should be perpendicular to the distal femoral cut surface to control the rotation of the tibia, and wherein the alignment of the limb can be controlled by centering the Y-shaped piece in the ankle/2nd toe. [00125] Exemplary embodiment 31: A system for aligning a knee during a surgical procedure without utilizing a robotic system or device, wherein the system is configured to utilize a distal femoral cut as a starting point reference for a proper tibial cut, the system comprising: a direct knee alignment device; an installation stage for the direct knee alignment device; and a removal stage for the direct knee alignment device.

[00126] Exemplary embodiment 32: Any of the previous exemplary embodiments further comprising, wherein the direct knee alignment device comprises: a femoral component comprising a metal component of a distal and an anterior aspect of a knee prosthesis; two or more tibial cutting guide components comprising a left tibial cutting guide component and a right tibial guide cutting component; two or more alignment rods; and a Y-shaped component. [00127] Exemplary embodiment 33: Any of the previous exemplary embodiments further comprising, wherein a femoral component can mimic a femoral implant, wherein the femoral component can be placed towards a center of a notch, and wherein the femoral component comprises one or more cavities on a perpendicular-plane to the distal femoral cut.

[00128] Exemplary embodiment 34: Any of the previous exemplary embodiments further comprising, wherein the two or more tibial cutting guides are configured to be disposed perpendicular to at least one of the two or more alignment rods and parallel to the distal femoral cut, wherein the two or more tibial cutting guides each comprise one or more cavities configured to couple each tibial cutting guide to a bone, wherein the two or more tibial cutting guides each comprise a screw mechanism configured to move the respective tibial cutting guide up and down, and wherein the two or more tibial cutting guides each comprise a locking mechanism configured to secure the respective tibial cutting guide to at least one of the two or more alignment rods.

[00129] Exemplary embodiment 35: Any of the previous exemplary embodiments further comprising, wherein the two or more alignment rods are further configured to: align a limb, control tibial rotation, control a depth of a cut, and control a slope of the cut, wherein the two or more alignments rods are configured to couple together at a proximal end of each of the two or more alignment rods, wherein the two or more alignment rods comprise a plurality of slots configured to couple with the Y-shaped component at each distal end of the two or more alignments rods, and wherein the two or more alignment rods comprise a respective laser mark at a midline in continuity with the plurality of slots, wherein the laser mark is graduated to define a depth of the cut.

[00130] Exemplary embodiment 36: Any of the previous exemplary embodiments further comprising, wherein the Y-shaped component comprises: a laser mark associated with the femoral component and the two or more alignment rods, and a slot perpendicular to a surface of the distal femoral cut configured to control rotation of a tibia, and wherein alignment of a limb is controlled by centering the Y-shaped component with at least one of an ankle or a second toe.

[00131] Exemplary embodiment 37: Any of the previous exemplary embodiments further comprising, wherein the installation stage for the direct knee alignment device comprises installation of each part of the system as follows: the femoral component, wherein the width of the femoral component is approximately 9 mm, which corresponds to a typical resection in typical femoral cuts and is equivalent to a section usually replaced by a knee prosthesis, wherein the femoral component adapts to the anterior femur cut and the distal femur cut previously performed on an axis defined by a surgeon, and wherein the femoral component comprises an anterior expansion component that is approximately parallel to the distal cut and perpendicular to the anterior cut, and wherein the anterior expansion component comprises a cavity aligned approximately perpendicular to the anterior expansion component and perpendicular to the distal cut; two metal bars that are each at least 35 cm in length that are configured to be coupled to each other to obtain a combined bar of at least 70 cm, wherein the two metal bars are configured to slide through the opening of the anterior expansion of the femoral part that is located in the center of the knee, and wherein the two metal bars are to establish a mechanical axis of a limb from a center of a femoral head to a center of an ankle through a center of a knee; a pin block associated with at least one of the two or more tibial cutting guides, wherein the pin block comprises a metal block of approximately 3 cm x 4 cm x 1.5 cm, wherein the pin block comprises a central hole configured to receive a bar to allow the pin block to slide along the bar, and wherein pin block comprises at least one entry on a side of the pin block that is configured to allow adjustment of the tibial cutting guide and define a position of the tibial cut; and the two or more tibial cutting guide components configured to define the tibial cut, wherein each of the two or more tibial cutting guide components comprises a respective set of one or more holes that allow adjustment to the bar to define a depth of the tibial cut and an angulation of the tibial cut, wherein the two or more tibial cutting guide components are configured to allow adjustment to the bar to align with a neutral mechanical axis of the limb, and that is also perpendicular to the femoral cut, and wherein a sagittal plane can be adjusted with a change of position of the tibia closer or further from the bar where the pin block of the tibial cut definition guide slides, and wherein one or more pins are installed to secure the position of the tibial cut prior to actually realizing a final cut. [00132] Exemplary embodiment 38: Any of the previous exemplary embodiments further comprising, wherein the removal stage comprises: removing one or more assembled guide bars, removing the pin block for the tibial cut guide, and removing the metal femur component, wherein the knee surgery can continue normally after the removal stage.

[00133] Exemplary embodiment 39: Any of the previous exemplary embodiments further comprising, wherein the system is configured to efficiently define the proper tibial cut utilizing the direct knee alignment device to properly align an extend limb with the neutral axis, wherein the alignment is performed in extension along with tibial cut definition, and delaying cut afterwards in flexion, wherein the tibial cut is safer according usual surgical procedure based on utilizing the direct knee alignment device.

[00134] Exemplary embodiment 40: Any of the previous exemplary embodiments further comprising, wherein the system is configured to define the tibial cut based on femoral cut and in alignment with neutral axis, wherein a final alignment of a limb is taken into account prior to the tibial cut, wherein alignment errors are avoided by performing tibial cut in a separated way without considering neutral axis and femoral cut in full extension position for the limb. [00135] Exemplary embodiment 41: Any of the previous exemplary embodiments further comprising, wherein the system is configured to avoid repeat tibial cuts by ensuring correct final alignment of the limb prior to initiating a first tibial cut.

[00136] Exemplary embodiment 42: Any of the previous exemplary embodiments further comprising, wherein the system is configured to define the tibial cut based on the distal femur cut to ensure that the tibial cut and the femoral cut are both parallel to each other and parallel to the ground with the limb in extension, wherein the tibial cut and the femoral cut comprise a neutral axis.

[00137] Exemplary embodiment 43: Any of the previous exemplary embodiments further comprising, wherein the tibial cut is defined and checked prior to executing the tibial cut, and wherein the tibial cut once defined can be performed in a safe manner in a flexion position. [00138] Exemplary embodiment 44: Any of the previous exemplary embodiments further comprising, wherein the tibial cut in the sagittal plane can be modified by bringing the tibia closer or further from the system.

[00139] Exemplary embodiment 45: Any of the previous exemplary embodiments further comprising, wherein the system is configured for a tibial cut to be made after an initial distal femoral cut and an initial anterior femoral cut.

[00140] Exemplary embodiment 46: Any of the previous exemplary embodiments further comprising, wherein the system further comprises a sub-system that controls a rotation of the tibia in the coronal plane, and wherein the sub-system comprises one or more components that keep a bar aligned with the knee and ankle axis.

[00141] Exemplary embodiment 47: Any of the previous exemplary embodiments further comprising, wherein the system does not require any external system or high cost additional system known in the surgical field, and wherein the surgery is performed in a usual and known environment by a surgical team and a support team in a standard operation room, without the need for a large or special operation room, nor is specially trained staff required and neither is expensive and bulky storage of technological equipment required.

[00142] Exemplary embodiment 48: Any of the previous exemplary embodiments further comprising, wherein the system is configured to be implemented during surgery within the range of approximately 5 to 10 minutes.

[00143] Exemplary embodiment 49: Any of the previous exemplary embodiments further comprising, wherein the system is configured to improve alignment of a knee that is compatible with any regular surgical procedure for knee alignment, and wherein the system is further configured to be compatible with any standard prosthetic system.

[00144] Exemplary embodiment 50: Any of the previous exemplary embodiments further comprising, wherein the system is compatible with any hospital and medical center, and wherein the system is compatible with any operating room and/or any facilities available for surgery. [00145] Exemplary embodiment 51: Any of the previous exemplary embodiments further comprising, wherein the system is configured to reduce cost and improve results of a conventional knee alignment surgery without the need for a highly complex infrastructure. [00146] Exemplary embodiment 52: A method for utilizing the system of any of the previous claims, wherein the system comprises the one or more components of the embodiments of the system previously described, the method comprising: prior to performing the surgical field and with the help of a fluoroscope, a femoral head and a center of the femoral head are identified on the side to be operated on and marked on the skin with an electrode button for electrocardiogram monitoring; preparing a regular sterile field, except that access of the axle bars to the hip and possibility of palpation of the electrode that defines the position of the center of the hip should be considered to be able to properly control the axis of the limb during surgery; performing a femoral cut according to standard surgical procedure, wherein a distal femoral cut and an anterior femoral cut are performed; installing the femoral component of the invention to the distal femur, wherein the femoral component is pinned to the distal femur; extending the limb, wherein the femoral component is installed and pinned on the limb being extended; installing one or bars for alignment of the invention by utilizing a central hole of the femoral component; moving the limb until an axis of the limb is in a neutral axis aligning a center of the hip, a center of the knee, and a center of the ankle, wherein the fluoroscope can be utilized to confirm the limb is aligned in the neutral axis; establishing the rotation of the tibia in relation to the anterior femoral cut with the bars and the Y -shaped component as an aid, wherein the laser marks of the bars are aligned with the femoral component such that the Y guide for the ankle can pass through a section perpendicular to the anterior femoral cut so the tibia can be aligned parallel to that plane using a maleolos or other preferred anatomical reference; placing the pin block of the tibial cutting guide in the alignment bar; adjusting the tibial cut guide to the block; after adjusting the tibial cut guide, adjusting the depth of the cut and keeping the previously defined axis aligned so that the pins will mark or define the tibial cut; sequentially removing of the system parts as previously described; repositioning the knee in flexion to prepare the limb for the tibial cut; and continuing with the usual technique used by the surgeon for each prosthetic model, including performing tibial cut.

[00147] Exemplary embodiment 53: Any of the previous exemplary embodiments further comprising, the method further comprising: wherein the femoral component further comprises: wherein part of the femoral component that represents a prosthetic implant, the depth of the two distal bars is shortened to allow adjustment to the measurement of all the knees, including the smaller ones in anteroposterior diameter, and additionally, the volume of the proximal component was decreased to make it more easily manipulated, wherein the anteriorly projecting bar receiving the alignment guide slides distally to a position even closer to the center of the knee, wherein the anteriorly projecting bar is extended to have space for three additional holes that can receive the alignment guide, and wherein, in case of patients with more voluminous thighs, wherein the three additional holes allow for space to raise the alignment guide and confirm the required axes including a mechanical axis of the femur and a frontal axis of the entire limb, wherein at least one wrench is held to fix the alignment guide, and wherein the linear laser mark of the complete bar is maintained that fixes the axis perpendicular to the distal femoral cut; wherein the tibial cutting guide system, further comprises: a right and a left component to adapt to the sliding system disclosed in FIGURE 12, a component that comprises the proximal -distal slide and the slide to bring the tibial cutting guide closer to the anteromedial aspect of the tibia, wherein the system is configured to prevent rotation of the tibial cutting guide in the axial plane, and wherein the system is configured to not allow changes in the sagittal axis, and wherein always keeping parallel to the distal cut of the femur; and wherein alignment guide was made thinner for the new integrated tibial cutting system, wherein the alignment guide maintains the laser mark to control and maintain the perpendicular relationship of the tibial cut to the guide and also for the use of the Y guide of the tibial rotation, wherein the alignment guide comprises graduated marks in millimeters incorporated at both ends of the alignment guide, wherein once affixed to the femoral component with a corresponding key, the graduated marks serve to determine the depth of the tibial cut by sliding the integrated cutting system the required number of millimeters, and wherein the alignment guide is configured to be placed in the upper holes of the femoral component in the case of more bulky thighs to maintain the relationship perpendicular to the distal femoral cut.

[00148] Exemplary embodiment 54: A device for aligning a knee during a surgical procedure without utilizing a robotic system or device, wherein the device is configured to utilize a distal femoral cut as a starting point reference for a proper tibial cut, the device comprising: a femoral component, wherein the femoral component comprises a metal component with the distal and anterior aspect of a conventional knee prosthesis in its femoral component; two or more tibial cutting guide components comprising a left tibial cutting guide component and a right tibial guide cutting component; two or more alignment rods; and a Y- shaped component.

[00149] Exemplary embodiment 55: Any of the previous exemplary embodiments further comprising, wherein the femoral component is configured to mimic the femoral implants, wherein the femoral component is configured to be placed towards a center of a notch, and wherein the femoral component comprises holes perpendicular-plane to a distal cut.

[00150] Exemplary embodiment 56: Any of the previous exemplary embodiments further comprising, wherein the set of tibial components can be disposed approximately perpendicular to the rod and therefore parallel to the distal femoral cut, wherein each tibial component of the set of tibial components comprises holes to pin the respective tibial component to the bone, and wherein each tibial component of the set of tibial components comprises a screw mechanism to slide up and down the tibial cutting guide, and wherein each tibial component of the set of tibial components comprises a knob to lock the respective tibial component to the alignment rod.

[00151] Exemplary embodiment 57: Any of the previous exemplary embodiments further comprising, wherein the two or more alignment rods are further configured to: align a limb, control tibial rotation, control a depth of a cut, and control a slope of the cut, wherein the two or more alignments rods are configured to couple together at a proximal end of each of the two or more alignment rods, wherein the two or more alignment rods comprise a plurality of slots configured to couple with the Y-shaped component at each distal end of the two or more alignments rods, and wherein the two or more alignment rods comprise a respective laser mark at a midline in continuity with the plurality of slots, wherein the laser mark is graduated to define a depth of the cut.

[00152] Exemplary embodiment 58: Any of the previous exemplary embodiments further comprising, wherein the Y-shaped component comprises: a laser mark associated with the femoral component and the two or more alignment rods, and a slot perpendicular to a surface of the distal femoral cut configured to control rotation of a tibia, and wherein alignment of a limb is controlled by centering the Y-shaped component with at least one of an ankle or a second toe.

[00153] Components of embodiments of the system (e.g., knee alignment system, etc.) can be physically and/or logically integrated in any manner (e.g., with any suitable distributions of functionality across the components, such as in relation to portions of embodiments of methods described herein; etc.).

[00154] In variations, components of embodiments of the system (e.g., knee alignment system, etc.) can be positioned at (e.g., mounted at, integrated with, located proximal, etc.) any suitable location (e.g., in relation to metal pieces, metal bars, pin blocks, etc.) and/or oriented in any suitable manner. Additionally, or alternatively, components of embodiments of the system can be integrated with any suitable existing components (e.g., existing surgical procedures, existing hospitals, etc.).

[00155] Components of the system can be manufactured using any one or more of: molding (e.g., injection molding, etc.), microlithography, doping, thin films, etching, bonding, polishing, patterning, deposition, microforming, treatments, drilling, plating, routing, CNC machining & casting, stereolithography (SLA), Digital Light Synthesis (DLS), PolyJet additive manufacturing technologies, Fused Deposition Modeling (FDM), suitable prototyping approaches, and/or any other suitable manufacturing techniques. Components of the system can be constructed with any suitable materials, including recyclable materials, plastics, composite materials, metals (e.g., steel, alloys, copper, etc.), glass, wood, rubber, ceramic, flexible materials, rigid materials, and/or any other suitable materials.

[00156] Embodiments of the method and/or system can include every combination and permutation of the various system components and the various method processes, including any variants (e.g., embodiments, variations, examples, specific examples, figures, etc.), where portions of embodiments of the method and/or processes described herein can be performed asynchronously (e.g., sequentially), concurrently (e.g., in parallel), or in any other suitable order by and/or using one or more instances, elements, components of, and/or other aspects of the system and/or other entities described herein.

[00157] Any of the variants described herein (e.g., embodiments, variations, examples, specific examples, figures, etc.) and/or any portion of the variants described herein can be additionally or alternatively combined, aggregated, excluded, used, performed serially, performed in parallel, and/or otherwise applied.

[00158] As a person skilled in the art will recognize from the previous detailed description and from the figures and claims, modifications and changes can be made to embodiments of the method, system, and/or variants without departing from the scope defined in the claims. Variants described herein not meant to be restrictive. Certain features included in the drawings may be exaggerated in size, and other features may be omitted for clarity and should not be restrictive. The figures are not necessarily to scale. The absolute or relative dimensions or proportions may vary. Section titles herein are used for organizational convenience and are not meant to be restrictive. The description of any variant is not necessarily limited to any section of this specification.

Claims

1. A system for aligning a knee during a surgical procedure without utilizing a robotic system or device, wherein the system is configured to utilize a distal femoral cut as a starting point reference for a proper tibial cut, the system comprising: a direct knee alignment device; an installation stage for the direct knee alignment device; and a removal stage for the direct knee alignment device.

2. The system of claim 1, wherein the direct knee alignment device comprises: a femoral component comprising a metal component of a distal and an anterior aspect of a knee prosthesis; two or more tibial cutting guide components comprising a left tibial cutting guide component and a right tibial guide cutting component; two or more alignment rods; and a Y -shaped component.

3. The system of claims 1 or 2, wherein a femoral component can mimic a femoral implant, wherein the femoral component can be placed towards a center of a notch, and wherein the femoral component comprises one or more cavities on a perpendicular-plane to the distal femoral cut.

4. The system of any of the preceding claims, wherein the two or more tibial cutting guides are configured to be disposed perpendicular to at least one of the two or more alignment rods and parallel to the distal femoral cut, wherein the two or more tibial cutting guides each comprise one or more cavities configured to couple each tibial cutting guide to a bone, wherein the two or more tibial cutting guides each comprise a screw mechanism configured to move the respective tibial cutting guide up and down the alignment rod, and wherein the two or more tibial cutting guides each comprise a locking mechanism configured to secure the respective tibial cutting guide to at least one of the two or more alignment rods.

5. The system of any of the preceding claims, wherein the two or more alignment rods are further configured to: align a limb, control tibial rotation, control a depth of a cut, and control a slope of the cut, wherein the two or more alignments rods are configured to couple together at a proximal end of each of the two or more alignment rods, wherein the two or more alignment rods comprise a plurality of slots configured to couple with the Y -shaped component at each distal end of the two or more alignments rods, and wherein the two or more alignment rods comprise a respective laser mark at a midline in continuity with the plurality of slots, wherein the laser mark is graduated to define a depth of the cut.

6. The system of any of the preceding claims, wherein the Y-shaped component comprises: a laser mark associated with the femoral component and the two or more alignment rods, and a slot perpendicular to a surface of the distal femoral cut configured to control rotation of a tibia, and wherein alignment of a limb is controlled by centering the Y -shaped component with at least one of an ankle or a second toe.

7. The system of any of the preceding claims, wherein the installation stage for the direct knee alignment device comprises installation of each part of the system as follows: the femoral component, wherein the width of the femoral component is approximately 9 mm, which corresponds to a typical resection in typical femoral cuts and is equivalent to a section usually replaced by a knee prosthesis, wherein the femoral component adapts to the anterior femur cut and the distal femur cut previously performed on an axis defined by a surgeon, and wherein the femoral component comprises an anterior expansion component that is approximately parallel to the distal cut and perpendicular to the anterior cut, and wherein the anterior expansion component comprises a cavity aligned approximately perpendicular to the anterior expansion component and perpendicular to the distal cut; two metal bars that are each at least 35 cm in length that are configured to be coupled to each other to obtain a combined bar of at least 70 cm, wherein the two metal bars are configured to slide through the opening of the anterior expansion of the femoral part that is located in the center of the knee, and wherein the two metal bars are to establish a mechanical axis of a limb from a center of a femoral head to a center of an ankle through a center of a knee; a pin block associated with at least one of the two or more tibial cutting guides, wherein the pin block comprises a metal block of approximately 3 cm x 4 cm x 1.5 cm, wherein the pin block comprises a central hole configured to receive a bar to allow the pin block to slide along the bar, and wherein pin block comprises at least one entry on a side of the pin block that is configured to allow adjustment of the tibial cutting guide and define a position of the tibial cut; and the two or more tibial cutting guide components configured to define the tibial cut, wherein each of the two or more tibial cutting guide components comprises a respective set of one or more holes that allow adjustment to the bar to define a depth of the tibial cut and an angulation of the tibial cut, wherein the two or more tibial cutting guide components are configured to allow adjustment to the bar to align with a neutral mechanical axis of the limb, and that is also perpendicular to the femoral cut, and wherein a sagittal plane can be adjusted with a change of position of the tibia closer or further from the bar where the pin block of the tibial cut definition guide slides, and wherein one or more pins are installed to secure the position of the tibial cut prior to actually realizing a final cut.

8. The system of any of the preceding claims, wherein the removal stage comprises: removing one or more assembled guide bars, removing the metal femur component leaving the tibial cutting guide pinned in place, completing the tibial cut, and removing the guide, wherein the knee surgery can continue normally after the removal stage.

9. The system of any of the preceding claims, wherein the system is configured to efficiently define the proper tibial cut utilizing the direct knee alignment device to properly align an extend limb with the neutral axis, wherein the alignment is performed in extension along with tibial cut definition, and delaying cut afterwards in flexion, wherein the tibial cut is safer according usual surgical procedure based on utilizing the direct knee alignment device.

10. The system of any of the preceding claims, wherein the system is configured to define the tibial cut based on femoral cut and in alignment with neutral axis, wherein a final alignment of a limb is taken into account prior to the tibial cut, wherein alignment errors are avoided by performing tibial cut in a separated way without considering neutral axis and femoral cut in full extension position for the limb.

11. The system of any of the preceding claims, wherein the system is configured to avoid repeat tibial cuts by ensuring correct final alignment of the limb prior to initiating a first tibial cut.

12. The system of any of the preceding claims, wherein the system is configured to define the tibial cut based on the distal femur cut to ensure that the tibial cut and the femoral cut are both parallel to each other and parallel to the ground with the limb in extension, wherein the tibial cut and the femoral cut comprise a neutral axis.

13. The system of any of the preceding claims, wherein the tibial cut is defined and checked prior to executing the tibial cut, and wherein the tibial cut once defined can be performed in a safe manner in a flexion position.

14. The system of any of the preceding claims, wherein the tibial cut in the sagittal plane can be modified by bringing the tibia closer or further from the system.

15. The system of any of the preceding claims, wherein the system is configured for a tibial cut to be made after an initial distal femoral cut and an initial anterior femoral cut.

16. The system of any of the preceding claims, wherein the system further comprises a set of elements that controls a rotation of the tibia in the coronal plane, and wherein the elements comprises one or more components that keep a bar aligned with the knee and ankle axis, wherein the elements can comprise the Y shape piece and the slots in the alignment bars

17. The system of any of the preceding claims, wherein the system does not require any external system or high cost additional system known in the surgical field, and wherein the surgery is performed in a usual and known environment by a surgical team and a support team in a standard operation room, without the need for a large or special operation room, nor is specially trained staff required and neither is expensive and bulky storage of technological equipment required.

18. The system of any of the preceding claims, wherein the system is configured to be implemented during surgery within the range of approximately 10 to 15 minutes.

19. The system of any of the preceding claims, wherein the system is configured to improve alignment of a knee that is compatible with any regular surgical procedure for knee alignment, and wherein the system is further configured to be compatible with any standard prosthetic system.

20. The system of any of the preceding claims, wherein the system is compatible with any hospital and medical center, and wherein the system is compatible with any operating room and/or any facilities available for surgery.

21. The system of any of the preceding claims, wherein the system is configured to reduce cost and improve results of a conventional knee alignment surgery without the need for a highly complex infrastructure.

22. A method for utilizing the system of any of the previous claims, wherein the system comprises the one or more components of the embodiments of the system previously described, the method comprising: prior to performing the surgical field and with the help of a fluoroscope, a femoral head and a center of the femoral head are identified on the side to be operated on and marked on the skin with an electrode button for electrocardiogram monitoring; preparing a regular sterile field, except that access of the axle bars to the hip and possibility of palpation of the electrode that defines the position of the center of the hip should be considered to be able to properly control the axis of the limb during surgery; performing a femoral cut according to standard surgical procedure, wherein a distal femoral cut and an anterior femoral cut are performed; installing the femoral component of the invention to the distal femur, wherein the femoral component is pinned to the distal femur; extending the limb, wherein the femoral component is installed and pinned on the limb being extended; installing one or bars for alignment of the invention by utilizing a central hole of the femoral component; moving the limb until an axis of the limb is in a neutral axis aligning a center of the hip, a center of the knee, and a center of the ankle, wherein the fluoroscope can be utilized to confirm the limb is aligned in the neutral axis; establishing the rotation of the tibia in relation to the anterior femoral cut with the bars and the Y-shaped component as an aid, wherein the laser marks of the bars are aligned with the femoral component such that the Y guide for the ankle can pass through a section perpendicular to the anterior femoral cut so the tibia can be aligned parallel to that plane using a maleolos or other preferred anatomical reference; placing the pin block of the tibial cutting guide in the alignment bar; adjusting the tibial cut guide to the block; after adjusting the tibial cut guide, adjusting the depth of the cut and keeping the previously defined axis aligned so that the pins will mark or define the tibial cut; sequentially removing of the system parts as previously described; repositioning the knee in flexion to prepare the limb for the tibial cut; and continuing with the usual technique used by the surgeon for each prosthetic model, including performing tibial cut.

23. The method of claim 22, the method further comprising: wherein the femoral component further comprises: wherein part of the femoral component that represents a prosthetic implant, the depth of the two distal bars is shortened to allow adjustment to the measurement of all the knees, including the smaller ones in anteroposterior diameter, and additionally, the volume of the proximal component was decreased to make it more easily manipulated, wherein the anteriorly projecting bar receiving the alignment guide slides distally to a position even closer to the center of the knee, wherein the anteriorly projecting bar is extended to have space for three additional holes that can receive the alignment guide, and wherein, in case of patients with more voluminous thighs, wherein the three additional holes allow for space to raise the alignment guide and confirm the required axes including a mechanical axis of the femur and a frontal axis of the entire limb, wherein at least one wrench is held to fix the alignment guide, and wherein the linear laser mark of the complete bar is maintained that fixes the axis perpendicular to the distal femoral cut; wherein the tibial cutting guide system, further comprises: a right and a left component to adapt to the sliding system, a component that comprises the proximal-distal slide and the slide to bring the tibial cutting guide closer to the anteromedial aspect of the tibia, wherein the system is configured to prevent rotation of the tibial cutting guide in the axial plane, and wherein the system is configured to not allow changes in the sagittal axis, and wherein always keeping parallel to the distal cut of the femur; and wherein alignment guide was made thinner for the new integrated tibial cutting system, wherein the alignment guide maintains the laser mark to control and maintain the perpendicular relationship of the tibial cut to the guide and also for the use of the Y guide of the tibial rotation, wherein the alignment guide comprises graduated marks in millimeters incorporated at both ends of the alignment guide, wherein once affixed to the femoral component with a corresponding key, the graduated marks serve to determine the depth of the tibial cut by sliding the integrated cutting system the required number of millimeters, and wherein the alignment guide is configured to placed in the upper holes of the femoral component in the case of more bulky thighs to maintain the relationship perpendicular to the distal femoral cut.

24. A device for aligning a knee during a surgical procedure without utilizing a robotic system or device, wherein the device is configured to utilize a distal femoral cut as a starting point reference for a proper tibial cut, the device comprising: a femoral component, wherein the femoral component comprises a metal component with the distal and anterior aspect of a conventional knee prosthesis in its femoral component; two or more tibial cutting guide components comprising a left tibial cutting guide component and a right tibial guide cutting component; two or more alignment rods; and a Y -shaped component.

25. The device of claim 24, wherein the femoral component is configured to mimic the femoral implants, wherein the femoral component is configured to be placed towards a center of a notch, and wherein the femoral component comprises holes perpendicular-plane to a distal cut.

26. The device of claims 24 or 25, wherein the set of tibial components can be disposed approximately perpendicular to the rod and therefore parallel to the distal femoral cut, wherein each tibial component of the set of tibial components comprises holes to pin the respective tibial component to the bone, and wherein each tibial component of the set of tibial components comprises a screw mechanism to slide up and down the tibial cutting guide, and wherein each tibial component of the set of tibial components comprises a knob to lock the respective tibial component to the alignment rod.

27. The device of claims 24-26, wherein the two or more alignment rods are further configured to: align a limb, control tibial rotation, control a depth of a cut, and control a slope of the cut, wherein the two or more alignments rods are configured to couple together at a proximal end of each of the two or more alignment rods, wherein the two or more alignment rods comprise a plurality of slots configured to couple with the Y - shaped component at each distal end of the two or more alignments rods, and wherein the two or more alignment rods comprise a respective laser mark at a midline in continuity with the plurality of slots, wherein the laser mark is graduated to define a depth of the cut.

28. The device of claims 24-27, wherein the Y-shaped component comprises: a laser mark associated with the femoral component and the two or more alignment rods, and a slot perpendicular to a surface of the distal femoral cut configured to control rotation of a tibia, and wherein alignment of a limb is controlled by centering the Y -shaped component with at least one of an ankle or a second toe.