A device for correcting rotational malalignment syndrome.

Abstract

The present invention relates to an appliance for correcting the growth of long bones in the rotational plane of the axis thereof, wherein the appliance comprises a fixing plate and a guide stop such that the plate and guide stop are fixed to each other, and the present invention also relates to minimally invasive techniques and positioning guides for the placement of the above appliance.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, preferably for the correction during growth advancement in the plane of rotation of the axis of long bones, particularly referring to fixation plates and guide stop devices for generating relative rotation of bone regions to which the plates and guide stops are respectively fixed, and the invention also refers to minimally invasive placement techniques for such devices.

Background Art

[0002] In the field of orthopedic surgery, particularly pediatric orthopedic surgery, there exists a rotational malalignment syndrome of the lower extremities that presents as a significant abnormality with excessive internal torsion at the femoral level and excessive lateral rotation of the tibia. Affected individuals, when standing, position their knees in a deviated inward position and their feet in a position of maximum external rotation.

[0003] The change in alignment may be constitutional, also known as physiological, or pathological. Generally, constitutional changes occur in normal individuals, i.e., those with normal growth, no signs of dysplasia, normal height, etc., and the deformities tend to be moderate and are often bilateral and symmetrical. In imaging examinations such as simple X-ray (XR) or computed tomography (CAT), no changes other than the deformity itself are detected. They have no known cause. They usually do not cause functional problems, but when severe, they cause aesthetic problems, changes in gait, and mechanical imbalances that promote early joint degeneration. Examples of these include femoral anteversion or developmental genu valgum. Second, there are other alignment changes caused by pathological causes, whether congenital or acquired. Any pathological osteoarticular process, whether traumatic, tumorous, inflammatory, infectious, or degenerative, is susceptible to causing deformities of the lower extremities. The treatment of these deformities consists of two aspects: treating the specific cause that causes it and treating the deformity itself.

[0004] Most children and adults walk with an average external rotation of 10 degrees. An internal rotation gait exceeding 10 degrees or an external rotation gait exceeding 30 degrees is considered pathological. This deformity usually occurs at the femur or tibia level and is diagnosed by a physician, along with a good clinical evaluation based on their knowledge of limb development in children, to distinguish between normal and pathological conditions.

[0005] Rotational malalignment is a common problem in children. At a young age, it often manifests physiologically and often corrects itself as the child grows. When the deformity is very pronounced or does not correct itself with age, the only clear solution at present is rotational correction through osteotomy and internal fixation of the bones involved.

[0006] Rotational osteotomy is an invasive surgery associated with several risks, such as bleeding, nonunion, displacement, incomplete or overcorrection, and risks associated with the implant used, such as implant rupture or failure associated with infection. It is also a surgery that involves hospitalization, delayed weight-bearing, and costs to the healthcare system.

[0007] For deformations in other planes, particularly the sagittal plane as well as the coronal plane, the use of growth-inducing devices that utilize and regulate the child's remaining growth to correct the deformation has long been proven and is well accepted.

[0008] For the correction of angle defects in the frontal and sagittal planes, the growth induction (figure-eight plate) proposed by Professor Peter Stevens has demonstrated the potential to determine a minimally invasive solution that does not require osteotomy, faster rehabilitation, and a temporary procedure, and that epiphyseal cartilage closure, i.e., when the desired correction is achieved, may be reversed.

[0009] So-called long bones have a region at their ends called the epiphysis, which extends towards the center of another region called the metaphysis, and towards the center of the bone's length, after which the body or diaphysis develops. Between the epiphysis E and the metaphysis M lies the growth cartilage, the epiphyseal cartilage fi. The growth cartilage is important for bone development.

[0010] Recent research has established the potential to use this concept for rotational deformities, i.e., axial plane correction. If achieved, less invasive techniques may be attainable, avoiding osteotomy and its associated complications.

[0011] Over the past decade, the idea has emerged to use growth induction in the axial plane to correct rotational immaturity in skeletons.

[0012] The first authors to investigate the feasibility of a rotational growth induction system were Arami, who in 2013 hypothesized that plate placement with both epiphyseal and metaphyseal implantation in an inclined configuration would induce subsequent rotation. The authors constructed a mathematical model and then tested it in rabbits using a rigid plate, achieving the desired angle correction and theorizing that the concept may be usable in the future. Notably, shortening occurs in connection with rotational correction, which may be considered a complication.

[0013] Following this announcement, two further studies can be found examining different aspects of the rotational growth induction generated by inclined rigid plates in rabbits. Cobanoglu studied 45 rabbits in 2016 to evaluate whether the method succeeded in generating rotations relevant to the growth of these animals. In 2017, Lazarus et al. took the study of the structure a step further, evaluating the relationship between the angle of plate placement and the generated rotations.

[0014] Aiming to advance the creation of knowledge in this field, Martel expanded his research in 2018 to large animals, particularly calves, and proposed different methods for generating rotation: one with two hollow screws at the metaphysis and the other at the epiphysis, and a structure having a circular wire passing through both and positioned at opposite inclinations in the lateral and medial sectors of the distal femur. He presents results demonstrating the clear generation of rotation related to the growth of the animal, along with the subsequent alignment of the positioned screws.

[0015] Based on more recent and previously mentioned research, two studies were conducted on humans.

[0016] In 2019, Metaizeau published a series of cases using a structure similar to Martel's in 20 distal femoral bones of the knee, demonstrating very good correction and establishing it as a possible effective alternative to rotational correction osteotomy. In a recent study in 2023, Paley published a series of cases using an implant with a similar principle, but with lower rigidity, employing an intermediate sector with a very high-strength tape that employs a long-chain polyethylene structure known under the brand name Fibertape; the surgery was performed to correct both internal and external rotation, as well as both the tibia and femur, and promising results were also reported.

[0017] The system proposed by Paley in the analyzed study uses two male semi-plates of a hinge plate system developed by Pegamedical, one screwed into the metaphyseal sector and the other into the epiphyseal sector, attached to the medial sector at a 45-degree angle with Artrhex Fibertape sutures, and the other to the lateral sector of the bone. See EFORT Open Reviews (2024) 9 119-128 https: / / doi.org / 10.1530 / EOR-23-0149, GENERAL ORTHOPAEDICS, "Correction of rotational deformities in long bones using guided growth: a scoping review" Ahmed Harlum 1, Suren Kold 1, Jan Dudal Rulfing 2, Ahmed A Abood 1,2 and Ole Rabek 1.

[0018] All systems analyzed to date to produce rotational correction, i.e., rotational growth induction, during bone growth propose structures with epiphyseal and metaphyseal implants that, after achieving the desired correction, must be removed in a manner that does not result in closure of the epiphyseal cartilage.

[0019] More precisely, to cause corrective rotation, that is, rotation between the bone and the epiphyseal plate, plates, bars, and wires are fixed, one end fixed to the plate and the other end fixed to the metaphysis, and extend obliquely. As a result, when the bone grows, the oblique plate or wire causes relative rotation between the bone and the epiphysis. However, after rotational correction is achieved, the implanted plates, wires, etc., must be removed to prevent delaying the axial growth of the bone, that is, to prevent metaphysical growth.

[0020] The surgical techniques used in these studies have not been analyzed in detail, or these studies present difficult processes for the correct positioning of the proposed structures, and these positioning techniques are fundamental for these systems to function properly.

[0021] While these new techniques are promising, they still need improvement in their function so that, in the best-case scenario, they release the elements causing the rotation just before they begin to act as growth inhibitors, thus avoiding the need to return to surgery to remove them. [Overview of the project]

[0022] Therefore, an object of the present invention is to provide a novel implantable plate system for rotational correction between bone and epiphysis that functions freely without the risk of causing growth inhibition after the syndrome being treated has been corrected or partially corrected.

[0023] Another objective of the present invention is to provide a rotational correction plate system that does not generate epiphyseal cartilage closure during growth induction and does not necessarily require a second surgery to release the system, and can continue to function with a small surgical procedure if correction in the rotational plane needs to be continued.

[0024] Another object of the present invention is to provide a plate comprising an epiphyseal implant and a metaphyseal extension portion, which presents at least one hole at the epiphyseal level to generate a bone implant that may or may not have a hollow block screw.

[0025] Another object of the present invention is to provide a plate comprising an epiphyseal implant and a metaphyseal extension portion, which presents at least one hole at the epiphyseal level to generate a bone implant that may or may not have a hollow non-block screw.

[0026] It is another object of the present invention to provide a plate with an epiphyseal retention and a metaphyseal extension presenting at least one hole at the epiphyseal level so as to create a bone retention allowing connection with the holes of the opposite symmetric plate.

[0027] It is another object of the present invention to provide a plate with an epiphyseal retention and a metaphyseal extension, the metaphyseal extension creating a fixed angle with the epiphyseal cartilage, being variable during manufacture, and preferably being 60 degrees.

[0028] It is another object of the present invention to provide a plate with an epiphyseal retention and a metaphyseal extension, the metaphyseal extension creating a fixed angle with the epiphyseal cartilage, being variable during manufacture, and allowing it to slide with respect to the metaphyseal stop where it is arranged.

[0029] It is another object of the present invention to provide a plate with an epiphyseal retention and a metaphyseal extension, the metaphyseal extension creating a fixed angle with the epiphyseal cartilage, being variable during manufacture, the metaphyseal extension may be solid or may present a complete or incomplete central recess for accommodating a metaphyseal stop arranged to allow its sliding.

[0030] It is another object of the present invention to provide a plate with an epiphyseal retention and a metaphyseal extension, the metaphyseal extension creating a fixed angle with the epiphyseal cartilage, being variable during manufacture, and the plate may be made of titanium, surgical steel or any other biocompatible material which may also be absorbable.

[0031] It is another object of the present invention to provide a bicortical metaphyseal element, which may be a screw or a rod, allowing formation of a stop on the arranged plate, for which purpose it must project from one or two cortical elements respectively.

[0032] Another object of the present invention is to provide bicortical metaphysical elements, which may be screws or rods, that allow for the formation of stops on the plate to which they are placed, and which may be made of titanium, surgical steel, or any other biocompatible material, or even a bioabsorbable material.

[0033] Another object of the present invention is to provide bicortical metaphysical elements that may or may not be hollow screws, fully or partially screwed in, and having self-tapping, self-perforating or blunt-headed tips, and which may form stops on the plate in which they are placed, so that each must protrude from one or two cortical elements, and such elements may or may not have screw-in washers associated with each side of the screw to form lateral stops and to prevent the system from disengaging, and to cover the tips of the screws to avoid damage to soft tissue or discomfort to the patient.

[0034] Another object of the present invention is to provide bicortical metaphysical elements that are hollow or non-hollow rods, partially or fully threaded, with a blunt tip, the tip of which may be shaped as an Allen key and may be positioned or removed from either side, forming a stop on the plate in which it is positioned, so that it must protrude from one or two cortical elements, each.

[0035] Another object of the present invention is to provide monocortical or bicortical metaphysical elements, which may form a stop on the ipsilateral plate, which may be a screw or similar, for which they must protrude from the cortical elements, and if a double plate is used, two of the elements must be positioned.

[0036] Another object of the present invention is to provide a monocortical or bicortical metaphysical element that may form a stop on the ipsilateral plate, which may be a screw or similar, for the purpose of which it must protrude from the cortical element, and if a double plate is used, two of the elements must be present and be made of titanium, surgical steel, or any biocompatible element, which may or may not be absorbable.

[0037] Another object of the present invention is to provide a metaphysical fixation element which may form a stop in the metaphysical extension portion of the ipsilateral plate, for this purpose it must protrude from the cortical element, and if a double plate is used, two of the elements must be positioned. They may be different forms of tubular systems which allow for the metaphysical extension portion of the plate and are fixed to the bone in different ways.

[0038] Another object of the present invention is to provide a metaphysical fixation element that may form a stop in the metaphysical extension portion of the ipsilateral plate, for which it must protrude from the cortical element, and if a double plate is used, two of the elements must be positioned. They may be different forms of staples that allow for the metaphysical extension portion of the plate and are fixed to the bone in different ways.

[0039] Another object of the present invention is to provide metaphysical fixation elements that may form a stop in the metaphysical extension portion of the ipsilateral plate, for this purpose they must protrude from the cortical elements, and if a double plate is used, two of the elements must be positioned. They are different forms of tubular systems that allow for the metaphysical extension portion of the plate and are fixed to the bone in different ways, or they are staple-like systems and may be made of titanium, surgical steel, or any biocompatible material, which may or may not be absorbable.

[0040] Another object of the present invention is to provide a metaphysical fixation element comprising a hollow screw protruding from both cortical layers, which is then screwed in by a fastening wire or cable surrounding the metaphysical extension portion of the plate in contact with the tip of the screw, and the fastening may form a stop on the metaphysical extension portion of the plate, which is fixed to the head of the screw.

[0041] Another object of the present invention is to provide a metaphysical fixation element comprising a hollow screw protruding from both cortical portions, which is then screwed in by a fastening wire or cable surrounding the metaphysical extension portion of the plate, and the fastening may form a stop on the metaphysical extension portion of the plate, which is secured to the head of the screw.

[0042] An object of the present invention is to provide an apparatus for correcting rotational malalignment syndrome in individuals suffering from the syndrome, wherein the apparatus comprises at least one fixation plate having a first end portion of a placement portion having a fixation means for fixing it to a first region of bone, and a second free end portion designed to extend onto a second region of bone without being fixed thereto; at least one guide stop designed to be fixed to the second region of bone; and at least one guide edge portion of the second free end portion for guided support relative to the guide stop.

[0043] A further object of the present invention is to provide a positioning guide for installing the apparatus of the present invention, comprising an internal and an external part that is movable toward or apart from one another, each of which the internal and external parts presents a sector designed to accommodate the shape of the fixing plate of the present invention, the sector comprising two cylinders for screwing in the installation wire, the sector being fixed to the respective arms that connect the telescopic connecting arms together in turn.

[0044] Another object of the present invention is to provide a method for arranging the above-mentioned positioning guides, which comprises the following steps: Step 1: Screw the pre-positioned metaphysical Kirschner wire into the bone through one of the cylinders in the internal and external parts of the guide; Step 2: Assemble the retractable arms; Step 3: Using an image enhancement device, position the placement guide in the profile so that one of the cylinders, which is a radiopaque hollow epiphyseal cylinder, is positioned at the center of the epiphyseal region, allowing the epiphyseal Kirschner wire to be placed in the correct position, and then remove the guide.

[0045] Another object of the present invention is to provide a method for installing the device of the present invention, comprising the following steps: Step 1: For example, position the metaphyseal Kirschner wire 1 cm at the metaphyseal level, parallel to the epiphyseal cartilage E on the anterior surface of the bone, and centered on the bone in the profile, and use an image enhancement device to determine the correct positioning; Step 2: Assemble a placement guide on the Kirschner wire via a cylinder, allowing for the identification of the correct positioning of the epiphyseal Kirschner wire; Step 3: Position the epiphyseal Kirschner wire through the guide, and then remove the guide; Step 4: Mill the metaphysical wire with a hollow bit and position both cortical hollow screws from the anterior side of the plate so that they protrude half a centimeter on each side of the bone, thereby positioning them upstream during rotation and facilitating their removal, and creating a metaphysical guide stop; Step 5: Perform an internal and external epiphyseal approach of 3 cm, centering the Kirschner wire and sliding the plate, along with the already installed guide stop, to contact the second end portion or the metaphyseal extension portion, wherein the sliding of the plate may be facilitated by placing a threaded guide sleeve in the central locking hole and thus using it as a handle; Step 6: Remove the epiphyseal Kirschner wire, position the plate with the central alignment hole where the Kirschner wire was located, mill it through the locking sleeve, position the locked central alignment screw through the plate, then position the second locked screw on each side, close it in a plane for proper cleaning and hemostasis, and control the final positioning of the instrument with an image enhancement device. [Brief explanation of the drawing]

[0046] For greater clarity and understanding of the object of the present invention, it is illustrated in several figures, and the present invention is shown in one of the preferred embodiments, all as illustrative examples. [Figure 1] This is a sagittal view of the distal femur of the left femur, in which a plate according to one embodiment of the present invention has been implanted; [Figure 2] This is a sagittal view of the distal left femur, in which two plates, an internal and an external, have been implanted, according to another embodiment of the present invention; [Figure 3] This is an axial view of the distal part of the left femur in which two plates, an internal and an external, are implanted according to the present invention; [Figure 4] This is a sagittal view of the distal left femur, equipped with internal and external mirror plates for generating external rotation of the distal femur; [Figure 5] This shows a sagittal view of the left proximal tibia equipped with a plate according to another embodiment of the present invention; [Figure 6] This shows a sagittal view of the left proximal tibia equipped with a double plate according to another embodiment of the present invention; [Figure 7] This is a sagittal view of the distal left femur, equipped with a plate according to another embodiment of the present invention; [Figure 8] This is a sagittal view of the distal left femur, equipped with a plate according to another embodiment of the present invention; [Figure 9] A diagram of two plates combined with a hollow screw, according to another embodiment of the present invention, is shown; [Figure 10] A diagram of two plates combined with bicortical rods, according to another embodiment of the present invention, is shown; [Figure 11] A diagram of two plates combined with two screws as metaphysical stops, according to another embodiment of the present invention, is shown; [Figure 12] A diagram of two plates combined with two staples as metaphysical stops, according to another embodiment of the present invention, is shown; [Figure 13] A diagram of two plates combined with two sleeves as metaphysical stops, according to another embodiment of the present invention, is shown; [Figure 14] A perspective view of a positioning guide used in implant technology, according to another embodiment of the present invention, is shown. [Figure 15] A sagittal view of a modified example of an epiphyseal implantation plate for the distal femur, according to another embodiment of the present invention, is shown. [Modes for carrying out the invention]

[0047] Referring to the figure, it can be observed that the present invention consists of a novel device for rotational correction of bone malformations.

[0048] As shown in Figure 1, the sagittal view of the distal left femur, generally indicated by reference F, and having region E, which is the epiphysis, and region M, which is the metaphysis, both of which have already been described above. Even when the femur is shown, it is important to clarify that the present invention is applicable to the correction of any human or animal bone having a rotational disorder.

[0049] According to embodiments of the present invention, the device shown in General Reference 1 comprises a preferably curved, generally angled plate 1.a having a first implantation end portion 1.e intended to be fixed to at least one of bone regions E or M, and a second free end portion 1.f or metaphysical portion intended to be free, i.e., it is not attached to any other region E or M of bone F. With respect to the terms used in this description, if the first end portion 1.e is intended to be implanted or fixed to the epiphysis, it may also be called the epiphysical implantation portion, and if the second end portion 1.f is intended to be free on the metaphysis, it may also be called the metaphysical extension portion.

[0050] The device 1 also includes a guide stop 1.d that is attached to a bone region E or M where the end 1.e of plate 1.a is not fixed. That is, when the plate is fixed to region E or the epiphysis defining the aforementioned epiphyseal implantation, the guide stop 1.d is fixed to region M or the metaphysis and is intended to define a guide support for plate 1.a along the edge 1.g of the plate.

[0051] Plate 1.a features at least one hole 1.b in its first end portion 1.e, intended to receive a fixing screw, which is not shown as it may be any of those well known in the art. If a single screw is used applied to hole 1.b, the type of screw and fastener should ensure the fixation of plate 1.a against rotation.

[0052] Alternatively, plate 1.a may include a second hole 1.c for receiving a second fixing screw, which can also be any type known in the art and is therefore not shown. Hole 1.c may be completely closed or open, as shown, because a screw placed in hole 1.c is not intended to fix plate 1.a to bone, which is the function of a screw applied to hole 1.b, the function of which is to prevent rotation of plate 1.a to the left, as shown in the figure and described below. For similar reasons, hole 1.c may simply be a groove or recess in the plate, or neither of these shapes is required in the plate profile.

[0053] As is known, bone growth originates from the epiphyseal cartilage, and then, over time, the metaphysis elongates axially away from the epiphyseal cartilage. According to the present invention, this bone elongation is used, in a desirable sense, to generate induced relative rotation between the epiphyseal cartilage and metaphysis, for example, to correct abnormal alignment of the lower limbs of individuals, typically children or teenagers in their growth stage.

[0054] In other words, the rotation is generated by the device of the present invention by utilizing bone elongation, i.e., growth. Together with the first end portion 1.e fixed to the epiphysis E and the guide stop 1.d fixed to the metaphysis M, as the bone grows away from the epiphysis, the guide stop 1.d moves axially away from the first end portion 1.e of plate 1.a, which is fixed to the epiphysis E and whose rotation is inhibited. Considering the cessation of the rotation, as the guide stop 1.d is supported against the edge 1.g of the plate and moves axially away from the hole 1.b, it rotates to the right in the direction of Figure 1. The edge 1.g forces the rotational displacement of the guide stop to the right in the figure by forming an angle with the first end portion 1.e, and thus forces the metaphysis to rotate relative to the epiphysis.

[0055] Therefore, there is a torsional effect between the epiphysis and metaphysis, generating relative rotation between them. The support between the guide stop and the fixation plate does not hold together any fixation that would hinder, lock, or stop the axial separation of the portions. In the worst case, which can certainly be predicted and calculated, the guide stop will move very far axially, exceeding the length of the end portion 1.f and disengaging from contact with the guide edge 1.g of plate 1.a. Thus, the individual's birth malalignment is corrected. Periodic image monitoring controls the correction, for example, to determine when the correction should be stopped.

[0056] Unlike known techniques that fix plates or wires obliquely to the epiphysis and metaphysis, this device is fixed to only one of them, and its major advantages are as follows: When a certain growth point is reached, i.e., a point at a certain distance between E and M, the conventional plates or wires, which were fixed obliquely to two regions E and F, are positioned axially aligned due to the rotation generated between E and M by the aforementioned distance. At this point, they begin to act as a barrier to further bone elongation or growth, and surgery must be performed to remove the plates or wires.

[0057] Unlike the above, plate 1.a forces relative rotation between E and M, but by not being fixed to the opposite side, in this case M, it allows for growth without restriction. The concept described in relation to the embodiment of the device in Figure 1 extends to all the remaining embodiments shown in Figures 2 to 13. In different embodiments, the shape of the plates and their placement or fixation, as well as the shape of the guide stops and their fixation, are modified. The epiphyseal sector or first placement portion 1.e of the plate may use screws of a type preferably known as locked screws. The epiphyseal anchor in 1.b of the plate may have one or more screws, preferably two screws, preferably locked or unlocked, hollow or non-hollow screws.

[0058] In short, the device 1 of the present invention generates an internal rotation effect on the distal femur during epiphyseal cartilage growth, and the guide stop having a screw or metaphyseal rod (1.d) does not hinder axial elongation of the bone. An advantage of the system is that although there is no metaphyseal implant, the guide stop that slides against the plate when moving axially may generate rotational correction of the bone without epiphyseal cartilage closure.

[0059] The epiphyseal fixation, i.e., the fixation of the first end portion 1.e of the plate, may be provided by locked or unlocked screws, which are conventional and therefore not shown, as well as by any other form of fixation that provides epiphyseal fixation and frees the metaphysical extension portion or second end portion 1.f of the plate.

[0060] In a preferred embodiment of the use of the plate of the present invention, the orthodontic appliance comprises a double plate for the femur, i.e., a combination of an inner and an outer plate, as shown by the dashed lines in the following figure, for more effective function.

[0061] As shown in Figure 2, the plate shown by the solid line is positioned on the anterior side of the bone, while the plate shown by the dashed line is positioned on the opposite side. This convention in illustrating the plates is repeated in the remaining figures illustrating the use of two plates. When two plates are used, one on each side of the femur, the metaphysical extension portion, or second end portion 1.f, of the plate is positioned in opposite directions, as shown in Figure 2 as an example, and has the same angle of inclination with respect to the epiphysis E and epiphyseal cartilage Fi, which may be variable, for example, a 60-degree inclination with respect to the epiphyseal cartilage Fi. The metaphysical extension portion, or second end portion 1.f, may be solid, or it may have a central recess open to the free end, or it may be closed, and may accommodate a guide stop, as seen in the embodiments described below.

[0062] Figure 2 shows a sagittal view of the distal left femur to which the device of the present invention is fixed, and in this embodiment, it comprises a symmetrical double plate, i.e, an inner plate 2.a and an outer plate 2.e, which share the central anchor hole 2.b, or may not share it if fixation by Kirschner wires locked on both sides of the plate with double locking screws is intended, and all of these components, wires, and screws are commonly used in the art. The guide stop of the present invention may be a bilateral cortical rod or screw 2.d that must protrude on both sides of the bone to produce a desired stop and rotational sliding effect on the plate. In this figure, the reference numbers begin with 2, but the plate portion is the same and equivalent as that in Figure 1. The reference numbers in subsequent figures begin with the number of the corresponding figure.

[0063] Both the internal and external plates may be attached with symmetrical epiphysis implants using fixed KWs with double locking heads. Depending on the direction of the metaphysis extension or the end portions 2.f of the internal and external plates, the effect of the metaphysis stop is to generate internal or external rotation of the bone.

[0064] Figure 3 shows an axial view of the left femur with an internal plate 3.a and an external plate 3.a', which is similar to or equivalent to those in Figures 1 and 2, and the guide stop comprises metaphysical screws or rods 3.d projecting to each side of the cortical layer at its ends to define guide stops where plate sliding occurs and a rotational effect on the plate is generated.

[0065] Figure 4 also shows a sagittal view of the distal left femur, which has an internal plate 4.a and an external plate 4.a' that mirror each other to generate external rotation of the distal femur at the epiphyseal cartilage growth and metaphyseal guide stop 4.d.

[0066] Preferably, the guide stop fixed to the metaphysis may comprise a screw or bicortical rod parallel to the epiphyseal cartilage, protruding from the medial and lateral portions of the cortical layer so as to be able to stop the end portions of both plates or the metaphyseal elongation portion, and moving away from the epiphyseal cartilage as the epiphyseal cartilage grows.

[0067] The design of the plate may vary depending on whether it is placed on the right or left femur, and depending on whether the desired effect is external or internal rotation of the bone during epiphyseal cartilage growth, as well as their mirror-image placement for the distal femur.

[0068] In another embodiment of the present invention, Figure 5 illustrates a sagittal view of the left proximal tibia T having a plate 5.a having a “7” shaped design, and the portion of the epiphysis implant includes two holes 5.c and 5.d intended to receive and fix a screw, together with considerations relating to the earlier embodiments of Figures 1 to 4, if the instrument of the present invention for femoral use is described.

[0069] Figure 6 illustrates two plates, an inner plate 6.a and an outer plate 6.a', as shown in Figure 5, which are also fixed to the left proximal tibia to generate internal rotation by a guide cap 6.d fixed to the metaphysis, along with the same considerations as in the previous embodiment established for the distal femur.

[0070] For the proximal tibia, the plate design of shape "7" is installed in a mirror configuration, depending on whether it is the right or left tibia, and whether the desired effect is external or internal rotation of the bone during epiphyseal cartilage growth.

[0071] In yet another embodiment of the present invention, Figure 7 illustrates a plate 7.a placed at the epiphysis, having an epiphysis retention portion and a metaphysis extension portion, the metaphysis extension portion presenting a central slot or central recess 7.g opening in its distal sector to accommodate and guide a guide stop 7.d.

[0072] In yet another embodiment of the present invention, Figure 8 illustrates a plate 8.a placed at the end of a bone, having an endoscopy portion and a metaphysical extension portion, the metaphysical extension portion presenting a closed central slot or central recess 8.g in its distal sector to accommodate and guide a guide stop 8.d.

[0073] The central slots 7.g and 8.g, each having at least one inner edge, are equivalent to the guide edges 1.g to 13.g and 15.g in the embodiments shown in Figures 1 to 13 and 15.

[0074] Figure 9 illustrates a preferred shape of the guide stop, which comprises a simple hollow screw 9.d on each side, defining the guide stop itself that abuts against the edge of the plate, which is guided axially and rotationally as it protrudes from both sides of the cortical layer. The screw may support two threaded washers 9.h to generate lateral stops of the plate and prevent the system from being released and also to keep the ends of the screw free from potentially causing injury to or discomfort to soft tissue.

[0075] In another embodiment, Figure 10 shows that when it is necessary to loosen or remove the instrument of the present invention, the guide stop is formed by two cortical rods 10.d having a multifaceted shape 10.i at both ends, similar to, for example, a "hex" wrench, for removal by either of the two ends.

[0076] In another embodiment, Figure 11 shows that the guide stop is formed by two screws 11.d that are independent of each other on each side of the bone.

[0077] In another embodiment, Figure 12 shows that the guide stop is formed by a stapler 12.d that extends and slides inside, allowing the second end portion 12.f to be free axially extended and causing a desired rotation.

[0078] In yet another embodiment, Figure 13 shows that the guide stop is formed by a sleeve or jacket 13.d that extends and slides inside, allowing the second end portion 13.f to be freely axially extended and causing a desired rotation.

[0079] Figure 15 illustrates another embodiment of the present invention and shows a sagittal view of the end of a long bone to which the device of the present invention is fixed. In this alternative, the fixing plate comprises two parts as seen in the other figures, a first retaining end portion 15.e and a second free end portion 15.f. The improvement provided in this embodiment is that the end portions 14.e and 15.f are connected to each other via a hinge having a hinge end portion 15.j and a hinge central portion 15.m. Preferably, portion 15.j is integral with the first retaining end portion 15.e and the hinge central portion 15.m is integral with the second free end portion 15.f, however, the portions may be reversed such that portion 15.j is integral with the second end portion 15.f and the hinge central portion 15.m is integral with the first retaining end portion 15.e. The structure allows for mobility in the frontal surface of the second end portion or free-extending portion 15.f, which is determined to accommodate the accompanying metaphysical diameter during the effect of rotational growth, and avoids it becoming a stopping element. When installed, once portions 15.e and 15.f are positioned in the desired location, the hinge portions 15.j and 15.m are locked or secured in place by pressure, friction, or by the teeth inside portions 15.j and 15.m, which can be tightened by internal screws 15.k.

[0080] Although the plate is illustrated with a first end portion 1.e fixed to the epiphysis or the epiphysis and metaphysis extension, or a second end portion 1.f fixed to the metaphysis, the assembly may be reversed, meaning that the first end portion 1.e may be fixed to the metaphysis and the second end portion 1.f may be fixed to the epiphysis, if the anatomical structure of the bone allows it. The reverse configuration is possible and within the scope of the invention, even if it may cause some discomfort when removing the device.

[0081] Furthermore, according to the present invention, a positioning / arrangement guide is provided as shown in Figure 14, comprising an internal portion 14.a and an external portion 14.b. The internal portion consists of a sector 14.a.1 designed to accommodate the shape of a plate and has two radiopaque cylinders, represented by a central alignment hole in the first end portion, for example, portion 1.e in Figure 1, the epiphysis hole of the plate 14.a.2, and another cylinder 14.a.3 into which the second end portion 1.f or metaphysical extension of the plate begins. The internal portion of the guide 14.a.1, having the shape of a plate, also features a rectangle 14.a.4, which is connected as a continuum to a horizontal hollow arm 14.b.5 of the external portion 14.b of the guide, preferably telescopically or in other ways. The external portion of the guide also consists of sectors 14.b.1 designed to accommodate the shape of the plate and has two cylinders for screwing in the Kirschner wire, a radiopaque one represented by the central alignment hole of the first end portion 1.e, an epiphysis hole of the plate 14.b.2, and a second end portion, for example, portion 1.f in Figure 1, or another cylinder 14.b.3 into which the metaphysical extension portion of the plate begins. The internal portion of the guide 14.b.1 having the shape of the plate comprises a rectangle 14.b.4 with an arm of a suitable shape as a continuum, preferably an arm 14.b.5 of the internal portion of the guide as a continuum after the metaphysical Kirschner wire has been screwed in by the two cylinders of the guide, the internal cylinder and the external cylinder.

[0082] The placement guide in Figure 14 was developed to enable the correct positioning of both plates of the instrument, e.g., the plates in Figures 1 to 13, and to perform surgical implant procedures for correct manipulation at the metamuscular guide stop, as also relating to the present invention.

[0083] Preferred surgical implantation methods A preferred method or technique for implanting the device of the present invention, according to the present invention, comprises the following steps: Step 1: The metaphysical Kirschner wire is positioned, for example, 1 cm at the metaphysical level, parallel to the epiphyseal cartilage E on the anterior surface of the bone, and centered in the bone profile, and its correct positioning is determined using an image enhancement device. Step 2: The placement guide is assembled on the Kirschner wire via cylinder 14.a.2, which allows for the identification of the correct position of the epiphyseal Kirschner wire. Step 3: The epiphyseal Kirschner wire is positioned via the guide, and then the guide is removed. Step 4: Milling is performed with a hollow bit via the metaphysical wire, and both cortical hollow screws are positioned. These are positioned from the anterior side of the plate, so that it is positioned upstream during rotation and its removal is facilitated.

[0084] Both cortical screws are positioned to protrude half a centimeter on each side of the bone to produce metaphysical guide stops, for example, 1.d in Figure 1 or the stops in the remaining embodiments.

[0085] Step 5: To ensure proper sliding of the epiphyseal plate, for example, plate 1.a, a 3 cm epiphyseal approach is made internally and externally, centered on the Kirschner wire, and together with the already installed guide stop, the plate slides into contact with the second end portion 1.f, or metaphyseal extension portion.

[0086] To facilitate the sliding of the plate, a threaded guide sleeve may be placed in the central locking hole, and thus used as a handle.

[0087] Step 6: The epiphyseal Kirschner wire is removed, and a plate is positioned with the central alignment hole 1.n where the Kirschner wire was located, and a central alignment screw is positioned via the locking sleeve and locked through plate 1.a, then a second locked screw is positioned on each side. It is closed by a plane that allows for proper cleaning and hemostasis, and the final positioning of the instrument is controlled by an image enhancement device.

[0088] How to place guides Furthermore, according to the present invention, a method or technique for using a positioning or placement guide comprises the following steps: Step 1: Screw the internal and external metaphysical hollow cylinders 14.a.3 and 14.b.3 of the guide 14 onto the metaphysical Kirschner wire positioned in the bone. Step 2: Assemble the internal horizontal 14.a.5, the physical rectangle, and the external hollow rectangle 14.b.5 extension of the guide. Step 3: Using an image enhancement device, position the placement guides in the profile so that the radiopaque epiphyseal hollow cylinders 14.a.2 and 14.b.2 are positioned at the center of the epiphyse, allowing the epiphyseal Kirschner wire to be placed in the correct position, and then remove the guides.

[0089] The placement guide allows for the determination of the distance and orientation of the epiphyseal Kirschner wire placement.

Claims

1. An apparatus for correcting rotational malalignment syndrome in patients suffering from the syndrome, wherein the apparatus is: At least one fixation plate (1.a) having a first implantation end portion (1.e) having fixing means (1.b-1.c) for fixing the fixation plate (1.a) to a first region (E) of the patient's bone, and a second free end portion (1.f) designed to extend over a second region (M) of the patient's bone, At least one guide stop (1.d) designed to be fixed to the second region (M) of the bone, The second free end portion (1.f) includes a guide edge portion (1.g) which is formed only on one side of the second free end portion (1.f) in order to provide guide support to the guide stop (1.d), The guide edge (1.g) of the second free end portion (1.f) extends only to one side of the guide stop (1.d), thereby guiding only one side of the guide stop (1.d) into contact with the guide edge (1.g), and any portion of the guide stop (1.d) opposite to the guide edge (1.g) is not in contact with the second free end portion (1.f), in the device.

2. The device according to claim 1, wherein the fixing means (1.b, 1.c) for fixing the fixing plate to the bone comprises at least one hole (1.b, 1.c) designed to receive a screw.

3. The device according to claim 2, wherein the fixing means (1.b, 1.c) comprises two holes.

4. The device according to claim 2, wherein the fixing means (1.b, 1.c) comprises the at least one hole (1.b) and a cavity (1.c) on the edge of the plate opposite to the guide edge (1.g).

5. The fixture according to any one of the preceding claims, wherein the fixing plate (1.a) is curved.

6. The apparatus according to any one of claims 1 to 4, wherein the first end portion (1.e) and the second end portion (1.f) of the fixing plate (1.a) form an angle between 30 and 70 degrees.

7. The device according to any one of the preceding claims, wherein the fixing plate (1.a) and the guide stop (1.d) are made of a material selected from the group comprising stainless steel, titanium, plastic, polymer, surgical steel, metal, biocompatible material, and absorbable material.

8. The device according to any one of the preceding claims, wherein the at least one fixation plate (1.a) comprises two plates designed to be implanted on opposite sides of the bone, respectively.

9. The apparatus according to any one of the preceding claims, wherein the guide edge portion (1.g) is the outer edge portion of the fixing plate (1.a) at the second free end portion (1.f).

10. The device according to any one of the preceding claims, wherein the guide stop (1.d) is selected from the group consisting of a rod, at least one screw, a hollow bicortical screw, a non-hollow bicortical screw, a fully threaded screw, a partially threaded screw, a self-tapping screw, a self-perforating screw, a blunt-headed screw, and a rod having a multifaceted end.

11. The device according to any one of claims 1 to 10, wherein the guide stop is a double cortical rod (10.d) configured to protrude from at least one of two cortical layers.

12. The device according to any one of claims 1 to 10, wherein the guide stop is a monocortical or bicortical screw configured to form a stop for the fixing plate (1.a), having the screw protruding from the cortical layer.

13. The apparatus according to any one of the preceding claims, wherein the first retaining end portion (15.e) and the second free end portion (15.f) are connected to each other via hinges (15.j, 15.m).

14. The device according to any one of the preceding claims, wherein the first region (E) of the bone is the epiphyseal region of the bone, and the second region (M) of the bone is the metaphyseal region of the bone.

15. A positioning guide for installing the fixture according to claim 1, comprising an internal portion 14.a and an external portion 14.b that are movable together, wherein each of the internal and external portions has sectors 14.a.1, 14b.1 designed to accommodate the shape of the fixing plate, the sectors comprising two cylinders for screwing in the installation wire, and the sectors being fixed to arms 14.a.4 and 14.b.4 that sequentially connect arms 14.a.5 and 14.b.5 that are telescopically connected to each other.

16. A method for positioning the positioning guide according to claim 15: Step 1: Screw the pre-positioned metaphysical Kirschner wire into the bone through the internal part of the guide and one of the cylinders of the external part; Step 2: Assembling the extendable arm; Step 3: Using the image enhancement device, position the placement guide in the profile such that one of the cylinders, which is a radiopaque hollow epiphyseal cylinder, is positioned at the center of the epiphyseal region that allows the epiphyseal Kirschner wire to be positioned correctly, and then remove the guide. A method for providing this.

17. A method for installing the device described in claim 1, comprising the following steps: Step 1: For example, position the metaphysical Kirschner wire 1 cm at the metaphysical level, parallel to the epiphyseal cartilage E on the anterior surface of the bone, and at the center of the bone in the profile, and determine the correct positioning using the image enhancement device; Step 2: Assembling the placement guide on the Kirschner wire via the cylinder, which allows for the identification of the correct position of the epiphyseal Kirschner wire; Step 3: Position the epiphyseal Kirschner wire through the guide, and then remove the guide; Step 4: Milling with a hollow bit through the metaphysical wire and positioning both cortical hollow screws from the anterior side of the plate so that they protrude half a centimeter on each side of the bone, thereby positioning them upstream during rotation and facilitating their removal, and creating the metaphysical guide stop; Step 5: Performing an internal and external 3 cm epiphyseal approach, which involves sliding the plate around the Kirschner wire, together with the already installed guide stop, to bring it into contact with the second end portion or the metaphyseal extension portion, wherein the sliding of the plate may be facilitated by placing a threaded guide sleeve in the central locking hole and thus using it as a handle; Step 6: Remove the epiphyseal Kirschner wire, position the plate in the central alignment hole where the Kirschner wire was located, mill the locking sleeve, position the central alignment screw locked through the plate, then position the second locked screws on each side, close it in a plane for proper cleaning and hemostasis, and control the final positioning of the instrument with an image enhancement device. A method for providing this.

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