A device for modulating growth plate activity and / or for orthodontic applications

Abstract

A device for modulating growth plate activity and / or for orthodontic applications, the device comprising: a first wire-like element (1) a first, preferably plate-like, fixation element (3), configured to be fixated on a bone or a tooth; wherein the first fixation element (3) comprises at least one receiving element (5), wherein the receiving element (5) is configured for receiving a fastening means, each receiving element preferably in the form of a through-hole in the fixation element (3), wherein the first fixation element (3) comprises a first guiding element (7), configured for guiding the first wire-like element (1), and wherein the first fixation element (3) comprises a first deflecting element (11) configured to deflect a portion of the first wire-like element (1); and wherein a first portion, preferably its first end-portion (14), of the first wire-like element (1) is configured to be fixated on a bone or a tooth; or wherein the first portion, preferably its first end-portion (14), of the first wire-like element (1) is fixated on a second fixation element (4), wherein the second fixation element (4) comprises at least one receiving element (6) configured for receiving a fastening means.

Description

[0001] A DEVICE FOR MODULATING GROWTH PLATE ACTIVITY AND / OR FOR ORTHODONTIC APPLICATIONS

[0002] FIELD OF THE INVENTION

[0003] The present invention relates to a device for modulating growth-plate activity or for orthodontic applications, more preferably for correcting limb deformities and limb length discrepancies by modulating growth plate activity of a bone growth plate, an assembly using such a device for these purposes, and a method and surgical kit using the device or assembly for the purpose.

[0004] BACKGROUND

[0005] Pediatric angular limb deformities and length discrepancies can be congenital, trauma / post- trauma related or caused by unbalanced growth plate activity. Current clinical practice uses plate and screw constructs that function as a tension-band and span the growth plate in a unilateral - or bilateral configuration to decelerate growth. These implants are not "passively" safe, which means that they require permanent observation, timely surgical intervention and their timely removal, as ongoing growth leads to steady rise of the reaction force of the fixation, and thereby potentially to plate and screw deformation and to devastating events like implant breakage of a screw and / or the implant, to complete growth arrest and / or to unwanted bone deformations. An example of such implants is disclosed in US 2012 / 0271358.

[0006] One problem associated with the above-described implant is that the force which it delivers is increasing with the bone growth over time. Therefore, these known implants have the inherent danger that the force exerted reaches a critical value which necessitates a surgical intervention in order to prevent breakage of the implant or a growth arrest of the growth plate. Another problem is the so-called "rebound effect”, i.e. the deceleration of the growth during the treatment with the implant frequently leads to accelerated growth after removal of the implant, which makes the desired effect void.

[0007] WO2018064781 proposes a device consisting of a wire to be used in an assembly comprising such a device and two bone screws, wherein the two bone screws are inserted proximally and distally to the growth plate, and wherein the device is secured to the protruding shafts of the two bone screws by means of loops, helices or coils, in which the helix-wound wire unwinds and, thus, exhibits a force to the growth plate acting against the direction of growth until the wire has fully unwound and the effect of the implanted device has vanished. Such devices overcome deficiencies of normal plate- and screw-assemblies. They show, however, limitations in relation to the force that may be exerted, and / or challenges due to the height of construction in the clinical application resulting from increased wire diameters for increase of the force exerted, and / or in general due to the construction height of helix- coiled wires.

[0008] SUMMARY OF THE INVENTION

[0009] It is, according to embodiments, the object of the present invention to provide a device which overcomes such disadvantages of the state of the art. In a preferred embodiment, the device of the present invention has the ability to continuously expand while exerting a substantially constant and / or displacement independent force to the growth plate over a clearly defined range of displacement and, at the same time, may show a similar construction height as conventional tension-band plate implants.

[0010] It is, according to embodiments, thus, the object of the present invention to provide a device suitable as an implant for clinical use, in particular for modulating growth-plate activity or for orthodontic applications, more preferably for inhibiting or slowing down growth plate activity, and / or for correcting uneven growth plate activity.

[0011] It is, according to embodiments, a further objective in view of known devices to increase the practicable forces against growth-plate activity of bones.

[0012] A solution to this problem is provided by the teaching of the independent claims. Various (preferred) embodiments of the present invention are provided by the teachings of the dependent claims.

[0013] According to an embodiment of the invention, a device for modulating growth plate activity, physeal plate activity, in particular bone growth activity and / or for orthodontic applications is provided. According to an embodiment, the device comprises a first wire-like element. According to an embodiment, the device comprises a first fixation element. According to an embodiment, the first fixation element is plate-like and / or comprises, at least substantially, a plate-like shape. According to an embodiment, the first fixation element comprises at least one receiving element, wherein the receiving element is configured for receiving a fastening means. According to an embodiment, the receiving element may comprise a through-hole in the fixation element or may be configured as a through-hole in the fixation element, in particular such that the fixation element may be affixed to an object, in particular a bone or a tooth. According to an embodiment, the first fixation element comprises a first guiding element. According to an embodiment, the first guiding element may be configured for guiding the first wire-like element, in particular with the help of at least one guiding surface of the first guiding element, further in particular when the first guiding element and the first wire-like element move or are moved relative to each other, further in particular for guiding the first wire-like element on and / or along the first fixation element. According to an embodiment, the guiding element is configured in such a way that a (predetermined) alignment and / or (predetermined) positioning of the first wire-like element can be or is achieved, in particular with regard to the first fixation element. According to an embodiment, the first fixation element comprises a first deflecting element. According to an embodiment, the (first) deflecting element is configured to deflect a portion of the first wire-like element. According to an embodiment, a first portion of the wire-like element, in particular and / or preferably, at least substantially, its first end portion, is configured to be fixated on a bone or a tooth. Additionally or alternatively, a first portion of the wire-like element; in particular and / or preferably, at least substantially, its first end portion; is configured to be fixated on a second fixation element, wherein the second fixation element comprises at least one receiving element that is configured for receiving a fastening means. According to an embodiment, the first fixation element is configured to be fixated on a first side of the growth-plate and the first wire-like element or the second fixation element is configured to be fixated on a second side of the growth-plate (that is different from the first side), in particular such that the direction of a tensile force may be, at least substantially, perpendicular to the growth-plate.

[0014] The term “guiding element” in the sense of the present invention may refer or refers to an element that is comprised by or that is, in particular integrally, part of the fixation element or is arranged at / on the fixation element and that is configured for (pre-)positioning and / or (pre-)aligning the wire-like element with respect to the fixation element and / or other elements that are comprised by the fixation element. The term “guiding element” does not refer to a part of a fastening means nor does the term “guiding element" refer to a fastening means itself. The term “guiding element” preferably refers to a part, in particular of the fixation element, that is different from a fastening means.

[0015] The term “deflect” in the sense of the present invention may refer or refers to changing a direction of a wire-like element as it passes through or around it, preferably around, in particular when the wire-like element moves or is moved relative to the fixation element and / or the deflecting element. According to an embodiment, the deflecting element is, in particular integrally, part of the fixation element or is arranged at / on, in particular a portion of, the fixation element.

[0016] The term "receiving element" in the sense of the present invention may refer or refers to an element that is configured for receiving a fastening means, in particular a “fastening means” in the sense of the present invention. In particular, the term “receiving element” may refer to an element that may comprise (additional) support for a fastening means and / or that may offer additional leverage point(s) for the respective fastening means, in particular for a (more) secure fastening of the (respective) fixation element. According to an embodiment, the receiving element is configured to introduce a lateral movement, in particular of the fixation element, or a lateral force when a bone screw is inserted into and / or tightened within the receiving element. According to an embodiment, the receiving element may comprise at least one inclined surface that may interact with a bone screw in a way that induces already a lateral movement and / or the lateral force leading to pre-tensioning the device at the time of fixation in the bone; for example, a receiving element may be designed as or similar to a bone plating compression hole.

[0017] The term "fastening means" in the sense of the present invention may refer or refers to a device or mechanism that is used to hold or secure two or more objects together. In an embodiment, it may refer to at least one of a screw, a bolt, a nail, a nut, a clip, a clamp, a hook, an adhesive, or any other similar device. According to an embodiment, the form of the fastening means may depend on the application and the objects being fastened.

[0018] In an embodiment, the receiving element and fastening means are selected / designed to result in an angular stable fixation, and / or a compression. In another embodiment, the receiving element and fastening means are selected / designed to allow for a variable angle fixation of the device.

[0019] According to embodiments, the device is (advantageously) based on a new principle using a deflecting element, which works in a comparable mode to a deflection roller, over which wire-like elements are bent and bent back, i.e. straightened, which allows to achieve a higher force level due to the plastic deformation work. The device of the present invention, according to embodiments, has the ability of, at least substantially, continuously expanding while exerting a, at least substantially, constant, in particular displacement-independent, force to the growth plate (of a bone) over a clearly defined range of displacement and / or in an orthodontic application. In addition, according to embodiments, it may advantageously avoid the stacking of wire-like elements in helically coiled ways in comparison to the state of the art and, thus, advantageously may show a decreased height of construction, which may lead to less or decreased tissue irritation(s) while implanted and / or applied in orthodontic applications. Furthermore, according to embodiments, each guiding means advantageously holds the respective wire-like element in a (pre-)defined position so that the wirelike element is dragged by the force produced by the growth at the bone growth plate (or the like) and is forced to undergo a plastic deformation, in particular two plastic deformations, one by being bent from its original substantially straight wire-like element form and a second one by being straightened again, in particular through the interaction of the deflecting element and the guiding element. Advantageously, according to embodiments, the device may be applied to inhibit or slow-down bone growth at a bone growth plate, in particular for a certain period of time, and / or to correct uneven growth plate activity. Advantageously, according to an embodiment, the device may guarantee a, at least substantially, constant force independent from the extension of the device, while the force exerted by the simple plate and screw devices according to the state of the art typically increases steadily with the growth of the bone. The accompanying advantage, according to an embodiment, is better control of the treatment and a more predictable outcome. The device according to an embodiment is passively safe, i.e. the force cannot reach (or exceed) a critical value which might provoke breakage of the device and / or fastening means or a growth arrest of the growth plate. Furthermore, according to an embodiment, the time point of force release and thus end of modulation, and in particular treatment, can be advantageously set by the extension length of the wire-like element(s). The device can, according to embodiments, be used simultaneously bilaterally on both sides of the bone, i.e. medially and laterally, whereas so far known state of the art plate-and-screw devices are typically developed for unilateral treatment, i.e. on one side of the bone / limb). This has, according to an embodiment, the advantage that it is advantageously possible to treat angular deformities, torsional deformities as well as discrepancies in the length of the leg(s) with a device as described herein. Further advantageously, according to an embodiment, the comparably, in particular with devices of the state of the art, low height of construction of the device, as described herein, at the side of implantation may, depending on the site of insertion, reduce soft tissue issues e.g. irritations and / or pain for the treated patient.

[0020] Advantageously, according to an embodiment, the exerted force may be adjusted by altering the thickness of the wire-like element and / or by adjusting the deflection / bending radius of the deflecting element; a person skilled in the art will be able to tailor these parameters for the specific needs and requirements of the application. According to an embodiment, this may (advantageously) allow to exert forces of at least 200 N and / or at most 750 N, or at least 350 N and / or at most 450 N, preferably around 400 N, in particular for angular deformity correction and leg length discrepancy correction around the knee, at distal femur and / or proximal tibia growth plates.

[0021] According to an embodiment, the second fixation element comprises a second guiding element. According to an embodiment, the second guiding element is configured for guiding the first wire-like element, in particular for guiding the first wire-like element on and / or along the second fixation element. According to an embodiment, the second fixation element comprises a second deflecting element configured to deflect the first wire-like element.

[0022] Advantageously, according to an embodiment, this may allow for a high(er) tensile force to be applied with the first wire-like element, in particular by exploiting the above described effect with the first wire-like element on the first fixation element as well as the second fixation element.

[0023] According to an embodiment the device comprises a second (further) wire-like element. According to an embodiment, the second fixation element comprises a second guiding element. According to an embodiment, the second fixation element is configured for guiding the second wire-like element, further in particular for guiding the second wire-like element on and / or along the second fixation element. According to an embodiment the second fixation element comprises a (second) deflecting element - that is in particular different from the first deflecting element as described herein. According to an embodiment the second deflecting element is configured to deflect the second wire-like element. According to an embodiment the second wire-like element is affixed with a first portion, preferably its first endportion, at the first fixation element. According to an embodiment, the device comprising a first fixation element and a second fixation element may be configured to be arranged on a bone, such that the device bridges a growth-plate of the bone, in particular in such a way that the growth of the growth-plate may be modulated, in particular influenced, at least substantially, section wise.

[0024] Advantageously, according to embodiments, a device that comprises two or more (independent) wire-like elements may allow for an even higher, in particular compared with the state of the art and / or a device comprising (only) a single wire-like element, tensile force to be applied with the device. According to an embodiment, the first guiding element may comprise at least two sub-guiding elements. The sub-guiding elements may be arranged at a beginning and an end of the first deflecting element. According to an embodiment, the at least two sub-guiding elements may be configured for guiding the respective wire-like element onto the first deflecting element (of the first fixation element). According to an embodiment, the second guiding element may comprise at least two sub-guiding elements. The sub-guiding elements may be arranged at a beginning and an end of the second deflecting element. According to an embodiment, the at least two sub-guiding elements may be configured for guiding the respective wire-like element onto the second deflecting element. According to an embodiment, the deflecting element may comprise at least two sub-guiding elements configured for guiding the respective wire-like element onto the respective deflecting element, in particular such that the wire-like element is deflected by the deflecting element, in particular when the wirelike element moves or is moved onto the deflecting element and / or is rectified, in particular when the wire-like element moves or is moved from the deflecting element through the (subguiding element. According to an embodiment, the sub-guiding element(s) may be arranged such that the (respective) wire-like element is, at least substantially, kept at a (deflecting-) surface of the deflecting element.

[0025] Advantageously, according to an embodiment, the sub-guiding element(s) (further) assist the guiding of the wire-like element on the fixation element. Further advantageously, the sub-guiding element(s) may allow for less material to be used while keeping up the herein described effect(s).

[0026] According to an embodiment, the deflecting element(s) comprise(s) an arch -like and / or a roller-like surface, in particular for deflecting / bending the wire-like element(s) along the (respective) surface. In an embodiment, the deflecting element is substantially of a circular or half-circular shape. In another embodiment, the deflecting element has a more extended arch-like or parabolic shape. According to an embodiment, the respective (deflecting) plane of the deflecting element(s) is, at least substantially, arranged within a layer that is, at least substantially, parallel to a surface layer of the bone, on which the respective fixation element is to be placed / fixated on.

[0027] Advantageously, according to an embodiment, this may allow for an, at least substantially, more even bending effect of the wire-like element and thus may allow for a more evenly provision of tensile force. According to an embodiment, the deflection element comprises a deflection radius of at least 2 mm and / or at most 8 mm, preferably at least 3.0 mm and / or at most 3.5 mm, preferably, at least substantially, 3.3 mm.

[0028] According to an embodiment, the deflecting element comprises at least two (deflection) radii, in particular at least two different radii, in particular along its deflecting surface. According to an embodiment, the deflecting element is, at least substantially, arch-like, such that the arch-like shape comprises, in particular at least, two radii, in particular different radii. The radii may be arranged in a consecutive manner or the arch-like shape of the deflecting element may comprise an, at least substantially, straight part arranged next to at least one of the radii or inbetween / interposed between the radii. According to an embodiment, the arch-like deflecting element may comprise a, in particular gradually changing, radius, further in particular at least with respect to a part and / or a section of the deflecting element or the arch-like shape, in particular along its length or across different sections. According to an embodiment, the deflecting element may comprise an elliptical portion or may be shaped ellipse-like, in particular at least partially.

[0029] Advantageously, according to an embodiment, this may allow for a (better and / or more evenly distributed) bending effect, in particular along the (respective) wire-like element. Advantageously, according to an embodiment, at least two radii and / or a gradually changing radius may allow for an, at least substantially, prolonged or continuous bending effect along the deflecting element and / or over a, in particular large(r), portion or multiple portions of the wire-like element that is / are in contact with the deflecting element. According to an embodiment, the deflection may advantageously result in (more) plastic deformation of the wirelike element which advantageously results in a higher (retaining) force level, in particular with respect to a fixation on a bone or a second fixation element.

[0030] According to an embodiment, the wire-like element comprises a plastically deformable material. Additionally or alternatively, according to an embodiment, the wire-like element comprises a metallic material. Additionally or alternatively, according to an embodiment, the wire-like element comprises a non-biodegradable material. Additionally or alternatively, according to an embodiment, the wire-like element comprises a cerclage wire or is a cerclage wire.

[0031] Advantageously, according to an embodiment, the use of a metallic material in the wire-like element may ensure strength and / or durability, in particular minimizing the risk of breakage during use. Furthermore, according to an embodiment, the use of a non-biodegradable material in the wire-like element may advantageously provide long-term stability and / or support, in particular reducing the need for repeat surgeries. Further advantageously, the use of a cerclage wire in the wire-like element may allow for secure fixation may allow for ease of use and / or compatibility with existing surgical instruments.

[0032] According to an embodiment, the wire-like element comprises at least one of a flat, rectangular and / or a circular section.

[0033] Advantageously, according to an embodiment, the shape of the cross-section may influence the tensile force that can or is applied, in particular during implantation and / or use of the device as described herein. Advantageously, according to an embodiment, the shape of the cross-section may influence the cost-effectiveness of the solution, as, depending on the shape of the cross-section, it can be made using standard manufacturing processes and / or materials.

[0034] According to an embodiment, the (respective) wire-like element comprises a diameter of less than 3 mm and / or more than 0.25 mm, preferably less or equal than 1.5 mm and / or more than 1.0 mm.

[0035] Advantageously, according to an embodiment, the use of a wire-like element with a diameter as described herein, allows for the wire-like element to be tailored to the specific needs and requirements of the application, particularly in modulating growth plate activity and / or for orthodontic applications, in particular ensuring improved performance.

[0036] According to an embodiment, the wire-like element is affixed to the fixation element by means of welding, crimping, pressing, gluing, is screwed on, in particular via a thread, further in particular via an external thread of the wire-like element, and / or hooked on.

[0037] Advantageously, according to an embodiment, this may allow for a secure and / or stable attachment of the wire-like element to the fixation element. Advantageously, according to an embodiment, the use of an external thread on the wire-like element provides a simple and / or efficient mechanism for attachment and adjustment, allowing for easy installation and / or removal. Advantageously, according to an embodiment, the fixation of the wire-like element may allow for temporary and / or reusable applications.

[0038] According to an embodiment, the opposing edges of the fixation elements are arranged, at least substantially, orthogonally to the direction of tensile stress. Advantageously, according to an embodiment, this may allow for a simple(r) placement of the fixation elements along the growth-plate or the epiphyseal line.

[0039] According to an embodiment, the opposing edges of the fixation elements are arranged, at least substantially, diagonally inclined to the direction of tensile stress.

[0040] Advantageously, according to an embodiment, this may allow for a simple(r) placement of the fixation elements along the growth-plate or the epiphyseal line and / or a sturdy (sturdier) fixation element with respect to the acting tensile stress, which may allow for less use material in the production of the fixation element and / or a small(er) height of the fixation element.

[0041] According to an embodiment, the device (further) comprises a recess for a mounting means. According to an embodiment, the recess for the mounting means is formed by one of the fixation elements; by the receiving means and / or by the opposing edges of the fixation elements.

[0042] Advantageously, according to an embodiment, this may allow for an improved mounting of the device. The recess may advantageously allow for a (more) secure and / or stable mounting of the mounting means as it may provide a defined space and / or support for the mounting means to engage with. Advantageously, according to an embodiment, this may allow for a (more) simplified design. By incorporating the recess into one of the fixation elements, the overall design of the device may be simplified, in particular it may reduce the number of parts and / or manufacturing steps required. Furthermore, the recess may help to distribute the force applied by the mounting means over a large(r) area, which may reduce the risk of damage or failure to the device. Advantageously, according to an embodiment, this may allow for an (more) cost-effective device, in particular by integrating the recess into the existing design of the device, rather than adding an additional component, the overall cost of manufacturing may be reduced.

[0043] According to an embodiment, a surface of the fixation element, in particular a surface of the first fixation element and / or the second fixation element, that is configured to be affixed on an anatomical structure, in particular a / the bone, further in particular of a patient, is precontoured or contoured to fit the anatomical structure, at least substantially. According to an embodiment, the (respective) surface of the fixation element is contoured such that this surface is, at least substantially, a matching counterpart for the anatomical structure. According to an embodiment, the wire-like element and / or the wire-like elements have a contact angle with their respective deflecting element of more than 40° and / or less than 220°, in particular more than 70° and / or less than 200°. According to an embodiment, the wire-like element and / or the wire-like elements have a contact angle with their respective deflecting element of, at least substantially, less than one turn.

[0044] Advantageously, according to an embodiment, this may allow for an improved contact between the wire-like element and the deflecting element, leading to a high(er) tensile force that is applicable with the device, in particular depending on the contact angle and further in particular an angle between the leading edge of the deflecting element and a (sub-)guid- ing element at that edge and / or an angle between the trailing edge of the deflecting element and a (sub-)guiding element at that edge of the deflecting element, which in turn influences the amount of bending of the wire-like element and / or the amount of (re-)straightening of the wire-like element.

[0045] According to an embodiment, the device is configured as a bone implant or is a bone implant. According to an embodiment, the device is configured as a dental brace or is a dental brace.

[0046] Advantageously, according to an embodiment, this may allow for an improved bone growth and / or fusion, which may help to stabilize and strengthen the bone. Furthermore, advantageously, according to an embodiment, the device may be customized to fit the specific needs and / or anatomy of the patient and / or a specific embodiment of the device may be selected in accordance with the application and / or specificities of the patient.

[0047] Advantageously, according to an embodiment, this may allow to help to correct crooked or misaligned teeth, which may in turn improve the patient's bite and / or oral health. According to an embodiment, the device can be made from materials that are tooth-colored or clear, which may (advantageously) render them less noticeable to others and / or which may improve the patient's confidence.

[0048] According to an embodiment, the device is, at least substantially, point-symmetrical.

[0049] Advantageously, according to embodiments, a device that is, at least substantially, point- symmetrical may allow for an (more) evenly high tensile force to be applied with the device, in particular with regard to a section of the bone(s) and / or with regard to a section of the growth-plate. Advantageously, according to an embodiment, this may allow for a simplifed design and / or manufacturing process of the device, in particular by reducing the number of unique components required, leading to cost savings and / or easier assembly.

[0050] According to an embodiment, at least one, in particularly, free end of the wire-like element comprises a slanted surface. According to an embodiment, the free end of the wire-like element is (thoroughly) deburred, rounded-off and / or chamfered, or not straight-cut but slanted, in particular to (advantageously) reduce a tensile force peak / peaks, further in particular when the wire-like element moves or is moved across a point where the end of the wire-like element leaves a sub-guiding element and / or the guiding element.

[0051] According to an embodiment, the material(s) of the wire-like element(s) and the material(s) of the fixation element(s) are selected to achieve a predetermined friction coefficient. According to an embodiment, the surface finish and / or the surface quality of the material(s) of the wire-like element(s) and the material(s) of the fixation element(s) are selected to achieve a predetermined friction coefficient.

[0052] According to an embodiment, at least one of the elements of the device is manufactured by additive manufacturing, in particular 3D printing, further in particular at least one of the fixation elements is manufactured by additive manufacturing, in particular 3D printing.

[0053] According to an embodiment, the device is configured such that the wire-like element(s) may be (minimally, i.e. such that the wire-like element(s) are moved more than 0.1 mm and / or less than 10 mm, in particular less than 5 mm) pre-bent, i.e. the device is pre-ten- sioned, respectively, before implantation and / or application. According to an embodiment, the device may allow for an initial (relative) movement of the wire-like element(s) in relation to the fixation element(s) for pre-bending. Advantageously, according to an embodiment, this may improve a, in particular earlier, establishment and / or stabilization of, at least substantially, constant force.

[0054] According to an embodiment, the receiving element is concentrically arranged with the deflecting element, in particular such that the wire-like element is, in particular guided and, deflected, at least substantially, concentrically with the receiving element and / or the fastening means.

[0055] Advantageously, according to an embodiment, this may allow for a (better) force transfer via the receiving element and / or the fastening means, in particular into the bone. According to an embodiment of the present invention, an assembly kit is provided. According to an embodiment, the assembly kit comprises a device as described herein. According to an embodiment, the assembly kit comprises fastening means, configured for affixing the device to a surface, in particular a bone surface and or a surface for orthodontic applications. According to an embodiment, a / the first fastening means is configured for insertion into the first receiving element. According to an embodiment, a / the second fastening means is configured for insertion into a / the second receiving element; alternatively or additionally, according to an embodiment, a / the second fastening means is configured to fasten the first wire-like element on a bone or a tooth, in particular dependent on the respective application.

[0056] Advantageously, according to an embodiment, this may allow for an improved bone modulation process and / or improved bone growth process.

[0057] According to an embodiment, the fastening means is / are selected from the group of bone screws, bone splints, bone staple, and bone cement. According to an embodiment, at least one of the fastening means or both of the fastening means are selected from the group of bone screws, bone splints, bone staple, and bone cement (or the like).

[0058] Advantageously, according to an embodiment, this may allow for a (improved) fixation of the fixation element on the respective (patient’s) anatomical surface.

[0059] According to an embodiment, wherein the fastening means is a bone screw, the bone screw comprises a smooth, preferably thread-less, upper end which is configured for contact with, particularly at least a portion of, the receiving element of the respective fixation element. According to an embodiment, wherein the fastening means is a bone screw, the bone screw comprises a cylindrical shaft section at an upper end, wherein the upper end is configured for contact with, particularly at least a portion of, the receiving element of the respective fixation element.

[0060] Advantageously, according to an embodiment, this may provide a larger surface area for contact with the receiving element of the fixation element. This increased surface area may (advantageously) improve the stability and / or strength of the connection between the bone screw and the fixation element. Furthermore, this may (advantageously) allow for a reduction of the risk of infection, as there are no sharp threads that can harbor bacteria and / or cause an infection. According to an embodiment, wherein the bone screw comprises a shaft section; the shaft section has a diameter equal or larger than 2.4 mm and / or smaller than 5.0 mm, preferably larger than 3.0 mm and / or smaller than 4.6 mm.

[0061] According to an embodiment of the present invention, a kit comprising two or more assemblies as described herein, is provided. According to an embodiment, one of the assemblies comprises a first device (comprising (only) a first fixation element) that in turn comprises an axis on the first fixation element, wherein the axis refers to a deflection axis of the first wirelike element, and a further axis, wherein the further axis an end-portion of the first wire-like element, in particular an end-portion that is configured to be fixed to a bone or a tooth. According to an embodiment, at least one of the assemblies comprises a first device (comprising a first fixation element and a second fixation element) that in turn comprises an axis on the first fixation element, wherein the axis refers to a deflection axis of the first wire-like element, and a further axis, wherein the further axis refers to a second axis of deflection of the first wire-like element on the second fixation element or refers to a deflection axis of the second wire-like element on the second fixation element. According to an embodiment, the distance between the axis and the further axis of the first device is at least 11.5 mm and / or at most 12.5 mm, particularly in a range of 11.6 to 12.4 mm. According to an embodiment, a further one of the assemblies comprises a further device, wherein the distance between the axis and the further axis is at least 15.4 mm and / or at most 16.6 mm, particularly in a range of 15.5 to 16.5 mm.

[0062] Advantageously, according to an embodiment, a surgeon can choose in situ from the kit, which of the comprised assemblies / devices fits (best) for the respective application.

[0063] According to an embodiment of the present invention, a method for modulating bone growth-plate activity is provided. According to an embodiment, the method comprises positioning a device as described herein, such that the device bridges a growth plate, in particular such that at least one wire-like element bridges the growth plate, further in particular, at least substantially, perpendicularly. According to an embodiment, the device, as described herein, is positioned such that one part of the device is arranged proximally and the further part of the device is arranged distally to a growth plate to be modulated, in particular such that the first wire-like element is affixed proximally to a growth plate to be modulated and guided by a guiding element and deflected by a deflection element distally to the growth plate or vice versa. According to an embodiment, the device, as described herein, is positioned such that the first wire-like element is affixed proximally to a growth plate to be modulated and guided by a guiding element and deflected by a deflection element distally to the growth plate and a second wire-like element is affixed distally to a growth plate to be modulated and guided by a guiding element and deflected by a deflection element proximally to the growth plate or vice versa. According to an embodiment, the method comprises predrilling holes for fastening means, in particular into a bone (or the like), further in particular such that a device (as described herein) can be affixed to the bone by setting the fastening means into the pre-drilled holes. According to an embodiment, the method comprises setting the fastening means into the pre-drilled holes. According to an embodiment, the method comprises fastening the fastening means in and / or to the bone, such that the device is fastened to the bone.

[0064] According to an embodiment, the holes are pre-drilled at a distance larger than the, in particular initial, distance between the receiving elements of the device, such that a prestressed condition of the device is or can be achieved.

[0065] According to an embodiment, the fastening means are secured and / or fastened in a torque limiting way, in particular in a / the bone.

[0066] According to an embodiment, the method comprises using the device, as described herein, to correct uneven growth plate activity. According to an embodiment, the device, as described herein, is applied to correct uneven growth plate activity.

[0067] Advantageously, according to an embodiment, this allows for a simple(r) way of correcting uneven growth, in particular by reducing the unevenness of the growth, in particular while allowing growth, at least substantially, in particular such that a rebound effect of growth is omitted.

[0068] According to an embodiment, a method for preparing the device, as described herein, for implantation is provided. According to an embodiment, the method comprises attaching a mounting means to the device.

[0069] The mounting means, according to an embodiment, allows a person to handle the device, e.g. a surgeon, to handle the device during the application with more ease and precise positioning. For this purpose, the device preferably further comprises a means for removable attachment of the mounting means, in particular a recess or hole. According to an embodiment, the attaching comprises pre-stressing the device, in particular with or by attaching the mounting means or before attaching the mounting means, in particular with means, such as e.g. a jack, winches and / or tensioners or the like, for pre-stressing the device. Advantageously, according to an embodiment, this allows for a (better) handling of the device and / or for the application of (pre-determined) tensile force, in particular across a growth plate, right from the start of the implantation of the device, in particular without a start-up period (with e.g. lower tensile force).

[0070] The terms “first”, “second”, “third” and the like in the description and in the claims, are used for distinguishing between similar elements and not necessarily for describing a sequential or chronological order. It is to be understood that the terms so used are interchangeable under appropriate circumstances and that the embodiments of the invention described herein are capable of operation in other sequences than described or illustrated herein.

[0071] Unless the context requires otherwise, where the term "comprising" or “including” or a variation thereof, such as “comprises” or “comprise” or “include”, is used in the present description and claims, it does not exclude other elements or steps and are to be construed in an open, inclusive sense, that is, as "including but not limited to".

[0072] Where an indefinite or definite article is used when referring to a singular noun e.g. "a" or "an", "the", this includes a plural of that noun unless something else is specifically stated.

[0073] Appearances of the phrases “according to an embodiments”, "in one embodiment" or "in an embodiment", if any, in the description are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments, unless such combination is explicitly excluded or technically impossible.

[0074] Further, unless expressly stated to the contrary, "or" refers to an inclusive or and not to an exclusive or. For example, a condition A or B is satisfied by any one of the following: A is true (or present) and B is false (or not present), A is false (or not present) and B is true (or present), and both A and B are true (or present).

[0075] BRIEF DESCRIPTION OF THE DRAWINGS

[0076] Further advantages, features and applications of the present invention are provided in the following detailed description and the appended figures, wherein: Fig. 1 schematically illustrates a device according to an embodiment;

[0077] Fig. 2 schematically illustrates how an embodiment of the device operates;

[0078] Fig. 3 shows a further embodiment of the device comprising a recess;

[0079] Figs. 4A to C shows a selection of embodiments of the device;

[0080] Fig. 5 schematically shows an embodiment of the device with connected mounting means and guide wire;

[0081] Fig. 6A to H schematically shows a selection of embodiments of the device; and

[0082] Fig. 7 A to B schematically shows embodiments with at least two, in particular different, radii.

[0083] In the figures, identical reference signs are used for the same, analogous or mutually corresponding elements of the embodiments described herein.

[0084] Although the method steps are described in conjunction with the systems of FIGS. 1-7, persons skilled in the art will understand that any system configured to perform the method steps, in any order, falls within the scope of the present invention.

[0085] DETAILED DESCRIPTION OF EMBODIMENTS

[0086] Fig. 1 shows an embodiment of the device, in particular as described herein. The device as shown comprises a first wire-like element 1 on a first fixation element 3 and a second wirelike element 2 on a second fixation element 4. The wire-like elements 1 ; 2 are guided by the guiding elements 8; 9 on the respective fixation elements 3; 4 such that the wire-like elements engage with the deflecting elements 11 ; 12 on the respective fixation elements 3; 4. The first wire-like element 1 is affixed to the second fixation element 4 at an end-portion 13, also marked with a black dot and the second wire-like element 2 is affixed to the first fixation element 3 at an end-portion 14, also marked with a black dot. According to an embodiment, this may in particular be achieved by laser welding the respective wire-like element to the respective fixation element. The device further comprises a first receiving element 5 and a second receiving element 6 with which the respective fixation elements 3; 4 may be affixed to an anatomical structure of a patient, in particular a bone that is to be modulated in its growth. An opposing edge 17 of the first fixation element 3 and an opposing edge 18 of the second fixation element 4 is shown. These opposing edges 17; 18 of the exemplary embodiment of figure 1 are shown to be arranged orthogonally to the direction of tensile stress, which in the shown figure corresponds to the direction of the straight wire-like elements. The guiding elements 7; 8 are divided in sub-guiding elements that are arranged such that the wire-like elements are guided onto the deflecting elements or are guided from the deflecting elements to be straightened (again).

[0087] Fig. 2 schematically illustrates how an embodiment of the device operates. The shown embodiment of the device comprises opposing edges that are arranged diagonally inclined to the direction of tensile stress. Fig. 2 shows the device in an initial position on the left, which according to embodiments may be a pre-stressed position and / or condition. Fastening means are not shown in Fig. 2, however, the fastening means establish (according to embodiments) a connection with the underlying anatomical feature / structure, such that the device may “grow” with the growing and / or moving anatomical feature / structure. For the sake of simplicity, the following non-limiting example refers to the device being used for modulating bone growth, where the device is in particular positioned across a growth plate and / or metaphyseal to the growth plate and epiphyseal to the growth plate, in particular for the exemplary embodiment of Fig. 2 where the first fixation element 3 is positioned metaphyseal to the growth plate and the second fixation element is positioned epiphyseal to the growth plate (or vice versa), the growth plate being represented by the dashed line. With the growth of the bone, the device is subjected to a dividing force between the (at least) two fastening points (where the fastening means are affixed to the bone) of the device. Consequentially, the wire-like elements 1 ; 2 move in accordance with their fixation (indicated by the black dots) such that a portion of the (respective) wire-like element 1 ; 2 is subject to bending, in particular at the deflecting element 11 ;12 and another portion of the (respective) wire-like element 1 ; 2 is subject to straightening, in particular such that a counter-force to the (forced) movement is created. The device is extended under, at least substantially, constant counter-force due to the bending and straightening of the wire-like elements 1 ; 2 until, in an embodiment, the device is explanted and / or the wire-like element(s) reach its / their maximum travel length. The counter-force can be, according to embodiments, be adjusted by the deflection radius of the deflecting element(s) 11 ; 12, parameters of the wire-like elements) 1 ; 2, such as diameter, material, cross-section or the like, and / or the number of deflection points and straightening points along (the length of) the wire-like element(s) 1 ; 2.

[0088] Fig. 3 shows a further embodiment of the device comprising a recess 20. The recess 20 in the shown embodiment is formed by the opposing edge 17 of the first fixation element 3 and the opposing edge 18 of the second fixation element 4 when the device is brought from an initial from into a pre-stressed form. The recess 20 is configured to receive mounting means with which the device may be (more easily) implanted and / or handled. The shown recess 20 in particular requires the device to be pre-stressed, such that the mounting means may be connected or inserted into the recess 20. Fig. 3 further shows slanted ends on the wire-like elements 1 ; 2. These slanted ends may allow for an easier movement of the wirelike elements through the sub-guiding elements, in particular without introducing tensile force peaks when the wire-like element 1 ; 2 leaves the guiding element 7; 8 and / or the subguiding element.

[0089] Figs. 4A to C shows a selection of embodiments of the device as described herein. The black dot references in each of the sub-figures that the respective wire-like element 1 ; 2 is attached at this location. The schematically shown embodiment of Fig. 4A shows a device with a single wire-like element spanning an exemplary growth-plate (schematically depicted by the dashed line), comprising a first and a second fixation element 3; 4 (not depicted entirely), where each of the fixation elements 3; 4 comprises a deflection element 11 ; 12 and a receiving element 5; 6. The guiding elements 7; 8 comprise multiple sub-guiding elements that guide the wire-like element 1 onto the respective deflecting element 11 ; 12 or from the respective deflecting element 11 ; 12. The wire-like element 1 may also be deflected in the opposite direction on one or both sides of the growth plate, according to an embodiment. According to an embodiment, the wire-like element 1 may also be arranged at an angle to the growth plate, with reference to Fig. 4A, in particular from a bottom right side to an upper left side of the respective deflecting elements 11 ; 12 or from a bottom left side to an upper right side of the respective deflecting elements 11 ; 12, depending on the application and / or the required tensile force. Fig. 4B shows an embodiment of the device with a greater contact angle on the respective deflecting elements 11 ; 12. Furthermore, the guiding elements 7; 8 (and / or their respective sub-guiding elements), according to an embodiment, may be used to introduce further bending and / or straightening along the wire-like element 1. Fig. 4C show a further embodiment of a device as described herein. The device comprises one side of the growth plate multiple deflecting elements 11 ; 1 T; 12. The further deflecting element 1 T, according to embodiments, comprises a deflecting element 1 T with a noncircular shape, i.e. an arch-like shape that comprises at least two different radii.

[0090] Fig. 5 schematically shows an embodiment of the device with mounting means 22 engaging a recess 20, wherein the recess 20 is designed for receiving the mounting means 22. Furthermore, Fig. 5 schematically shows a guide wire 21. According to an embodiment, the mounting means 22 are configured to be guided by the guide wire 21 , in particular for implantation.

[0091] Fig. 6A to H schematically show embodiments of the device. Dashed lines for indicating the receiving element(s) 5; 6 refer to the receiving element(s) 5; 6 being occupied by fastening means.

[0092] Fig. 7 A to B schematically shows embodiments, in particular of a deflecting element 11”, with at least two, in particular different, radii. The different radii are indicated with r1 and r2 respectively and are, in case of Fig. 7A arranged, such that the deflecting element 11” comprises two different radii r1 , r2 in a consecutive arrangement. Fig. 7B schematically shows an arrangement with two different radii r1 , r2 with an interposed straight (,i.e. at least substantially infinite radius) portion. According to an embodiment, the radii refer to the direction the wire-like element is guided along by the deflecting element. According to an embodiment, the deflecting element may comprise (another) radius, at least substantially, perpendicular to the guiding direction, in particular a grove that is, in an embodiment, configured to keep the wire-like element on the deflecting element. According to embodiments, the first deflecting element 11 , 11’, 11”, 1 T” and / or the second deflecting element 12 may comprise at least two different radii, in particular, at least substantially, further in particular as schematically shown in Fig. 7 A to B.

[0093] While above at least one exemplary embodiment of the present invention has been described, it has to be noted that a great number of variation thereto exists. Furthermore, it is appreciated that the described exemplary embodiments only illustrate non-limiting examples of how the present invention can be implemented and that it is not intended to limit the scope, the application or the configuration of the herein-described apparatus and methods. Rather, the preceding description will provide the person skilled in the art with constructions for implementing at least one exemplary embodiment of the invention, wherein it has to be understood that various changes of functionality and the arrangement of the elements of the exemplary embodiment can be made, without deviating from the subject-matter defined by the appended claims and their legal equivalents. LIST OF REFERENCE SIGNS first wire-like element second wire-like element first fixation element second fixation element first receiving element second receiving element first guiding element second guiding element sub-guiding element sub-guiding element ; 11’, 11”, 1 T” first deflecting element second deflecting element end-portion of the first wire-like element end- portion of the second wire-like element opposing edge of the first fixation element opposing edge of the second fixation element recess guide wire mounting means

Claims

CLAIMS1. A device for modulating growth plate activity and / or for orthodontic applications, the device comprising: a first wire-like element (1) a first, preferably plate-like, fixation element (3), configured to be fixated on a bone or a tooth; wherein the first fixation element (3) comprises at least one receiving element (5), wherein the receiving element (5) is configured for receiving a fastening means, each receiving element, preferably in the form of a through-hole, in the fixation element (3), wherein the first fixation element (3) comprises a first guiding element (7), configured for guiding the first wire-like element (1), and wherein the first fixation element (3) comprises a first deflecting element (11) configured to deflect a portion of the first wire-like element (1); and wherein a first portion, preferably its first end-portion (14), of the first wire-like element (1) is configured to be fixated on a bone or a tooth; or wherein the first portion, preferably its first end-portion (14), of the first wire-like element (1) is fixated on a second fixation element (4), wherein the second fixation element (4) comprises at least one receiving element (6) configured for receiving a fastening means.

2. The device according to the preceding claim, wherein the device comprises the second fixation element (4) and wherein the second fixation element (4) comprises: a second guiding element (8), configured for guiding the first wire-like element (1) and a second deflecting element (12) configured to deflect the first wire-like element (1).

3. The device according to any of the preceding claims, wherein the device comprises the second fixation element (4) and further comprises: a second wire-like element (2); and wherein the second fixation element (4) comprises a second guiding element (8) configured for guiding the second wire-like element (2); and wherein the second fixation element (4) comprises a second deflecting element (12) configured to deflect the second wire-like element (2);wherein the second wire-like element (2) is affixed with a first portion, preferably its first end-portion (13), at the first fixation element (4).

4. The device according to any of the preceding claims, wherein the first guiding element (7) and / or the second guiding element (8) comprises at least two sub-guiding elements, preferably arranged at a beginning and an end of the respective deflecting elements (11 ; 12), in particular for guiding the respective wire-like element (1 ; 2) onto the respective deflecting element (11 ; 12).

5. Device according to claim 1 or any of the preceding claims 2 to 4, wherein the first deflecting element (11) and / or the second deflecting element (12) comprises an arch-like or a roller-like surface.

6. Device according to the preceding claim, wherein the arch-like or roller-like surface of the deflecting element has a deflection radius of at least 2 mm and / or at most 8 mm, preferably at least 2.5 mm and / or at most 3.5 mm, preferably, at least substantially, 3.3 mm.

7. Device according to any of the preceding claims, wherein the first wire-like element (1) and / or the second wire like-element (2) comprises a plastically deformable material; and / or wherein the first wire-like element (1) and / or the second wire like-element (2) comprises a metallic material; and / or wherein the first wire-like element (1) and / or the second wire like-element (2) comprises a non-biodegradable material; and / or wherein the first wire-like element (1) and / or the second wire like-element (2) comprises a cerclage wire.

8. Device according to preceding claims 1 or 2 or any of preceding claims 3 to 7, wherein the first wire-like element (1) and / or the second wire like element (2) comprises a flat, a rectangular and / or a circular cross-section.

9. Device according to any of the preceding claims, wherein the wire-like element (1 , 2) has a diameter of less than 3 mm and / or more than 0.25 mm, preferably equal or less than 1.5 mm and / or more than 1 .0 mm.

10. Device according to any of the preceding claims, wherein the wire-like element (1) or the wire-like elements (1 ; 2) are affixed to the fixation element (3; 4) by means of welding, crimping, pressing, gluing, are screwed on, and / or hooked on.

11. Device according to any of the preceding claims, wherein the opposing edges (17; 18) of the fixation elements (3, 4) are arranged orthogonally to the direction of tensile stress.

12. Device according to any of the preceding claims, wherein the opposing edges (17; 18) of the fixation elements (3, 4) are arranged diagonally inclined to the direction of tensile stress.

13. Device according to any of the preceding claims, wherein the device further comprises a recess for a mounting means, in particular wherein the recess for the mounting means is formed by one of the fixation elements (3, 4); by the receiving elements (5; 6) and / or wherein the recess for a mounting means is formed by the opposing edges of the fixation elements.

14. Device according to the preceding claim, wherein the recess for a mounting means is readily formed by the opposing edges of the fixation elements in a ready-to-use pre-stressed state of the device and / or wherein a surface of the fixation element that is configured to fit an anatomical surface to be affixed on is pre-contoured.

15. Device according to any of the preceding claims, wherein the first wire-like element and / or the second wire-like element have a contact angle with their respective deflecting element (11 ; 12) of more than 40° and / or less than 220°, in particular more than 70° and / or less than 200°.

16. Device according to any one of the preceding claims, wherein the device is a bone implant or wherein the device is a dental brace.

17. Device according to any one of the preceding claims, wherein the receiving element (5; 6) is configured to introduce a lateral movement or a lateral force when a bone screw is inserted into the receiving element (5; 6).

18. Assembly for modulating bone growth plate activity, comprising:(i) a device according to any one of the preceding claims;(ii) a first fastening means configured for insertion into the first receiving element (5); and(iii) a second fastening means configured to fasten the first wire-like element (1) on a bone or a tooth or configured for insertion into the second receiving element (6).

19. Assembly according to the preceding claim, wherein one or both fastening means are selected from the group of bone screws, bone splints, bone staple, and bone cement.

20. Assembly according to any one of the preceding claims 18 and 19, wherein the fastening means is or are bone screws; and wherein one bone screw or both bone screws comprise a smooth, preferably thread-less, preferably cylindrical shaft section at an upper end which is configured for contact with the receiving element of the respective fixation element.

21. Assembly according to the preceding claim, wherein the bone screw comprises a shaft section; and wherein the shaft section has a diameter equal or larger than 2.4 mm and / or smaller than 5.0 mm, preferably larger than 3.0 mm and / or smaller than 4.6 mm.

22. A Kit comprising one or more assemblies according to any of the preceding claims 18 to 21 , wherein the distance between an axis of the first fixation element and a further axis of the second fixation element is in the range of 11.6 - 12.4 mm and for another Device of the kit is in the range of 15.5 - 16.5 mm.

23. Method for modulating bone growth plate activity, comprising the steps:(i) positioning a device according to any one of the preceding claims 1 to 17, in particular on a bone to be treated bridging the growth plate of said bone;(ii) setting the first and second fastening means,(iii) fastening the fastening means in the bone, and thus, fastening the device to the bone.

24. Method according to claim 23, wherein the holes are pre-drilled at a distance larger than, in particular an initial, distance between the two receiving elements (5, 6) of the device.

25. Method according to claims 23 or 24, wherein the first and second fastening means are secured in a torque limiting way.

26. Method according to claims 23 to 25, wherein the device is applied to correct uneven growth plate activity.

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