This application claims the benefit of Australian provisional Patent Application Serial No. 2020902937, filed Aug. 18, 2020, for “BONE FIXATION SYSTEM AND METHOD” by Huan Yuan, Owen John Bawden, Kelly Coverdale, Christopher Arnold Jeffery, Jarred James Bairstow, Jayaraman Somu, and Shanthan Pather, the disclosure of which is incorporated herein by reference.
The present invention relates to a locked bone fixation assembly, and in particular to an assembly that allows for a surgeon-selected angle of the bone screw relative to the fixation device.
Any references to methods, apparatus or documents of the prior art are not to be taken as constituting any evidence or admission that they formed, or form part of the common general knowledge.
Bone fixation systems for the internal fixation of bone fractures are known. Such systems are particularly well-suited to promote the healing of a fracture. A bone screw (also known as a bone anchor) is inserted through a bone plate hole (also known as an anchor hole or a screw hole) and is threaded into bone to compress, neutralize, buttress, tension bend, and/or bridge the fracture ends together and draw the plate against the bone. These screws are not secured or locked to the bone plate and can be threaded into bone at various angles relative to the bone plate. However, because the screws are not secured to the bone plate, the angular relationships between the plate and screws are not fixed and can change intraoperatively and/or postoperatively. That is, dynamic loading on the bone and bone plate from physiological conditions can cause the screws to loosen or back out with respect to the plate ultimately leading to poor alignment and poor clinical results.
Securing the screws to the plate provides a fixed angular relationship between the screws and plate and reduces the incidence of loosening. One known method of securing the screw with the bone plate is the use of screw threads on the screw head which can be secured with threads provided along inner walls defining the screw holes of the bone plate. These screws commonly referred to as “locking screws” are typically inserted coaxially with the central axis of the hole. Because the relationship between locking screws and the plate is fixed, the locking screws and plate act as a single unit which provides high resistance to shear, torsional, and bending forces. However, such locking screws are limited in their ability to compress bone fragments, which affects healing. Moreover, bone plates that use locking screws such as the system described in U.S. Pat. No. 9,155,577 which allow variable angle fixation are normally very thick. Here are the advantages of the reconstruction plates: Bone fixation plates are relatively massive plates, typically made of a hard titanium grade or titanium alloys with a material thickness of 2.0 to 3.5 mm, which are very stable and can absorb high forces. These reconstruction plates are usually designed so that the bending areas lie between the screw holes, wherein the openings and bending areas strung together like a string of pearls. The bending zones allow the plate to be anatomically adapted to the bone fragments, opening to opening.
Despite their specially designed deformation areas, reconstructive plates are difficult to adapt to the particular bone shape. To bend the plates very high forces may be required due to the material thickness and the material strength. Due to the large forces required, the bending tools must be designed to be strong, accurately fitting and with corresponding lever paths. Thicker bone plates are also known for causing irritation to surrounding soft tissues which leads to high rates of bone plate removal. As a result, it is desirable to provide bone fixing plates with a lower profile that can allow variable angle locking of the screw head.
Another issue associated with currently available bone plates that allow variable angle locking of the screw head relates to reusability of the bone plate. Often, the orthopaedic surgeon may need to change the orientation of the screw after an initial drilling operation. Many of the currently available bone plates that allow variable angle locking do not allow the same screw holes to be used repeatedly because the threads or the other engagement mechanisms become permanently damaged after a single use.
Yet another issue with some of the currently known bone plates and associated bone screws is that their screw head locking mechanisms function independently of the compression mechanism of the bone screw. As a result, the screw head in some instances may lock with the hole of the bone plate even though the screw has not fully compressed the bone plate.
In view of the above, it is desirable to provide an improved bone fixation system that addresses at least some of the problems of the prior art.
In an aspect, the invention provides bone fixation system for reconstruction and/or trauma treatment of bones, the system comprising: a bone fixation plate configured and dimensioned for application to a patient's bone, the bone plate comprising an in-use upper surface and an in-use lower surface with at least one opening formed on the upper and lower surfaces to form a passage extending from the upper surface to the lower surface; each passage being defined by one or more non-threaded inner walls extending from the upper surface to the lower surface of the bone plate to receive a bone screw; and resiliently deformable interference portions located along an in-use upper portion of the one or more inner walls, the interference portions being dimensioned to define the width of the passage to be smaller than the diameter of the head of the bone screw to achieve deformation of the interference portions and interference between the head of the bone screw and the inner walls to lock the head of the bone screw within the passage upon insertion of the bone screw into the passage at a variable angle of rotation relative to a longitudinal axis of the passage that is substantially perpendicular to the upper surface of the bone plate.
In an embodiment, each opening is defined by a plurality of inner walls such that adjacently located inner walls are separated by a recessed channel.
In an embodiment, the recess extends between the upper surface and the lower surface of the bone plate.
In an embodiment, the recess is substantially parallel to an imaginary longitudinal axis passing through the opening.
In an embodiment, the bone fixation system comprises a plurality of said recesses, the recesses being circumferentially arranged relative to the opening of the bone plate.
In an embodiment, portions of the one or more inner walls comprise a curved surface.
In an embodiment, the one or more inner walls comprises a concave surface.
In an embodiment, the upper portions of the inner walls comprise a concave spherical surface.
In an embodiment, said portions of the innerwalls of the opening converge towards in an in-use downwardly direction from the upper surface to the lower surface thereby decreasing the diameter of the opener in an in-use downwardly direction.
In an embodiment, diameter of the opening defined by the inner walls gradually deceases in an in-use downwardly direction from the upper surface to the lower surface.
In an embodiment, the inner walls define a convergent passage converging towards the lower surface of the bone plate for engaging the head of the bone screw.
In an embodiment, said portions of the inner walls defining the opening on the upper wall into the passage to be smaller than the diameter of the head of the bone screw comprise a substantially planar surface positioned for abutment with an upper rim of the head of the bone screw.
In an embodiment each said interference portion is located in an in-use upper portion of the corresponding inner wall.
In an embodiment, said interference portions of the inner wall are formed from deformable material such that interference between the head of the bone screw during use results in deformation of at least the said portions to allow the head of the bone screw to be locked into the passage.
In an embodiment, the bone fixation system comprises a plurality of the interference portions being circumferentially arranged relative to the opening of the upper surface, the interference portions being along the inner walls defining the passage such that upon insertion of the bone screw at a variable angle of rotation relative to a longitudinal axis of the passage that is substantially perpendicular to the upper surface of the bone plate and the head of the bone screw engages one or more of said portions thereby locking the head of the bone screw with the inner walls.
In an embodiment, the opening of the upper edge of the head of the bone screw comprises a bevelled or filleted edge.
In an embodiment, the head of the bone screw comprises a planar in-use upper portion an a curved in-use lower portion such that upon insertion of the bone screw into the opening, the planar upper portion of the head of the screw engages with said portions of the inner wall to lock the head with the inner walls defining the passage.
In an embodiment, the curved lower portion of the head is a substantially spherical surface configured to allow the lower portion of the head to be seated into the passage along the inner walls.
In another aspect, there is provided a method of affixing a bone screw to a bone fixation plate at a desired orientation, comprising the steps of: providing a bone screw comprising a non-threaded head portion with a driver engaging interface and an adjoining elongate threaded shank section comprising helical threads; providing a bone fixation plate comprising an in-use upper surface and an in-use lower surface with at least one opening formed on the upper and lower surfaces to form a passage extending from the upper surface to the lower surface; each passage being defined by one or more non-threaded inner walls extending from the upper surface to the lower surface of the bone plate to receive the bone screw; and resiliently deformable interference portions located at in-use upper portions of the one or more inner walls are dimensioned to define the width of the passage to be smaller than the diameter of the head of the bone screw; positioning said bone fixation plate on bone tissue such that the in-use lower surface of the bone fixation plate is positioned to contact and engage the bone tissue and positioning the in-use upper surface for receiving the shank portion of the bone screw; selecting one of a plurality of different insertion angles at which the bone screw is to be inserted into the passage of the bone fixation plate; inserting the elongate shank of the bone screw into the a passage opening located on the upper surface of the bone fixation plate at the selected insertion angle and applying drive to the head of the bone screw until interference is achieved between an outer surface of the head of the bone screw and the interference portions of the inner walls of the bone fixation plate to deform the interference portions and lock the head of the bone screw within the passage upon insertion of the bone screw into the passage at the selected angle of insertion.
Preferred features, embodiments and variations of the invention may be discerned from the following Detailed Description which provides sufficient information for those skilled in the art to perform the invention. The Detailed Description is not to be regarded as limiting the scope of the preceding Summary of the Invention in any way. The Detailed Description will make reference to a number of drawings as follows:
The three inner walls 135, each comprise interference portions 137. In the preferred embodiment, the interference portions 137 are circumferentially arranged relative to the opening 130A on the upper surface of the bone fixing plate 100. As shown clearly in the top view of the plate hole 130 in
The width for the opening of the upper surface 110 is large enough to allow the convergent lower spherical portion 214 of the bone screw 200 to pass through. Referring specifically to
Unlike the curved surface of the inner walls 135, the interference portions 137 comprise a planar configuration which reduces the width across the opening 130A of the upper surface 110 and results in deformation of the interference portion 137 and the inner walls 135 as the bone screw 200 passes through the passage 130 (at the variable angle of rotation) and the upper region 212 if the screw head 210 comes into contact with the planar surface of interference portions 137. The circumferentially arranged recessed channels 139 are configured and dimensioned to accommodate any deformation of the inner walls 135 and the interference portions 137 which is caused as a result of the interference portions 137 being engaged by the upper region of the screw head 210.
The upper cylindrical region 212 which is in the form of a rim has a height h1 and engages the interference portion 137 that has an overall length m1. In the preferred embodiment, the length m1 (shown in
The bone plate 100 and the bone screw 200 can be made from metal, a resorbable or non-resorbable plastic, ceramic, or composite materials. Suitable materials may include, for example, titanium, stainless steel, cobalt chrome, polyetheretherketone (PEEK), polyethylene, ultra high molecular weight polyethylene (UHMWPE), resorbable polylactic acid (PLA), polyglycolic acid (PGA), combinations or alloys of such materials or any other appropriate material that has sufficient strength to be secured to and hold bone, while also having sufficient biocompatibility to be implanted into a body.
Turning now to the methods of implantation, the surgeon accesses the surgical site of interest, which can be an internal site at which a bone fracture is located that requires stabilization to ensure proper healing. The fracture may be reduced with conventional forceps and guides (which are known to those in the art), and a bone plate such as but not limited to the specific configuration of the bone plate 100 may be placed over the fracture site. The bone plate such as the bone plate 100 may comprise of a plurality of plate holes 130 arranged like a string of pearls to suit the specific site of interest. The number of plate holes 130 provided in the bone plate 100 is not limiting. Similarly, the configuration of the bone plate 100 specifically the solid regions of the plate 100 between the plate holes 130 may be curved or bent and therefore the bone plate 100 may be formed in a variety of different configurations.
In some instances, the bone plate 100 may be temporarily secured to the bone (not shown) using provisional fixation pins. The provisional fixation pins may be used through either the provisional pin openings, or any other openings on the plate 100. For ease of explanation, the provisional pin openings have not been shown in the figures. Provisional fixation provides for temporarily securing the bone plate 100 to the bone before placing bone fixation screws 200 through the bone plate 100, so that one can be certain the bone plate 100 is properly positioned before placing bone screws for permanent fixation of the bone plate 100 to the bone.
Once the bone plate 100 is secured at a desired location in relation to the fracture (typically using one or more provisional fixation pins, although any other appropriate method may be used), the surgeon then identifies an insertion angle at which the bone screw 200 is to be inserted through the plate hole 130 and driven into bone tissue. After selecting the desired insertion angle and the plate hole 130, the surgeon inserts the shaft 220 of the fastener bone screw 200 through the opening 130 until the tip 225 of the shank 220 contacts bone tissue. In some cases, a hole may need to be pre-drilled or tapped into the bone tissue along the chosen insertion angle to facilitate the initial tapping or insertion of the bone screw 200. The surgeon then uses an appropriate driving tool to apply rotational torque to the screw head 220. The screw head 210 may be provided with an appropriate driver engaging interface. In the preferred embodiment, the bone screw 200 is provided with a hexagonal head for interfacing with the driving tool. It would be understood that the hexagonal head configuration is not limiting and any other suitable configuration such as but not limited to a torx head interface may also be provided in alternative embodiments.
It is important to note that the configuration of the bone plate 100, particularly the provision of the interference portions 137 along the upper portions of the inner walls 135 allows the screw head 210 to be locked within the plate hole 130 at a plurality of orientations. In this instance, the bone screw 200 may be inserted at angles such as in the range of 1 to 30 degrees in any direction (as shown in
Through extensive trials and experiments, the inventor has found that the provision of the deformable interference portions 137 in the configuration as previously described, allows the locking arrangement provided by the interference portions 137 to be re-used for locking the screw head 210 at a slightly different angle of orientation without significantly damaging the locking arrangement provided by the interference portions. Without being bound by theory, it is hypothesized that on first instance, when the upper rim region 212 engages one or more of the interference portions 137, both the upper rim region 212 and the contacting interference portions 137 undergo some level of deformation which may be elastic deformation. When the bone screw 200 is pulled out by applying rotational torque in the reverse direction, the interference portion 137 and the upper rim region 212 are no longer under engagement which may result in the interference portion 137 and the upper rim region 212 of the bone screw 200 fully returning to its original dimensions (under elastic deformation). In other instances, the interference portions 137 and the upper rim region 212 of the screw head 210, upon interference may undergo plastic deformation and after removal of the bone screw 200, the interference portion 137 and the upper rim region 212 of the screw 210 may only partially return to their original dimensions. It is theorised that providing a locking mechanism for the screw head 210 that relies on interference and elastic deformation of the interference portions 137 and the upper rim region 212 of the screw head 210 allows the screw hole 130 in the bone plate 100 to be used repeatedly for engaging the screw head 210 of a bone screw 200 at a variety of angles. The deformation mode of locking the screw head 210 provided by the bone fixing plate 100 allows the screw holes 130 to be utilised repeatedly. Of course, it would also be appreciated by a skilled person that many materials particularly metals cannot undergo elastic deformation infinite number of times. At least in some instances particularly when the bone fixing plate 100 and the bone screw 200 are formed from metallic materials, after been subjected to repeated stresses, the interference portions 137 and/or the upper rim region 212 of the screw head 212 may undergo metal fatigue and as a result may not completely recover to their original dimensions.
Once the bone fragment is secured by the threads provided on the shank portion 220 of the bone screw, the screw head 210 is locked to the inner walls 135 of the screw hole 130 in the bone plate 100. The interference portions 137 are located along an upper portion of each inner wall 135 in close proximity to the opening 130A of the upper surface 110. As explained earlier, the interference portions 137 engage with the upper rim region 212 of the screw head 210. As a result, the locking mechanism is engaged only after the shank 220 (with the threads for effecting compression of the bone fragments) of the bone screw 200 has passed through the plate hole 130 and the lower head portion 214 is at least partially seated along the curved surface of the inner walls. The location of the interference portions 137 and the rim 212 of the screw head 212 allows the bone fragments to be held under compression and push the bone fixing plate 100 onto the surface of the bone tissue before locking the screw head 210 with the plate hole 130. In some prior art systems that allow variable angle locking, the screw head for bone screws of such systems locks with the plate before the plate has been fully pushed onto the surface of the bone tissue under compression. The bone fixation system 1000 addresses this issue.
The configuration of the locking system provided by the interference portions 137 and the screw head 210 also allows the thickness of the bone fixing plate 100 to be lesser than bone fixing plates used for some of the known bone fixation systems that provide variable angle locking. The lowering in thickness for the bone fixing plate 100 has been achieved by providing the locking mechanism only in the upper region of the plate hole 130. Many other prior art bone fixation systems use plates with plate holes where by the entire height of the plate hole (and thickness of the bone fixing plate) is utilised for variable angle locking.
It would be understood by a skilled person that in some instances only some of the plate holes 130 may be used in conjunction with locking bone screw screws 200. The surgeon may place covers over the unused openings, particularly if there are any unused openings that cross the fracture, to strengthen the plate 100. Additionally or alternatively, the surgeon may also use bone graft material, bone cement, bone void filler, and any other material to help heal the bone.
A number of implementations of the invention have been described. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the invention. Accordingly, other implementations are within the scope of the following claims. For example, locking screws, non-locking screws, or other fasteners may be used. It also to be understood that in at least some embodiments, the bone screw 200 may be inserted in a substantially perpendicular orientation as shown in
In compliance with the statute, the invention has been described in language more or less specific to structural or methodical features. The term “comprises” and its variations, such as “comprising” and “comprised of” is used throughout in an inclusive sense and not to the exclusion of any additional features.
It is to be understood that the invention is not limited to specific features shown or described since the means herein described comprises preferred forms of putting the invention into effect.
The invention is, therefore, claimed in any of its forms or modifications within the proper scope of the appended claims appropriately interpreted by those skilled in the art.
Number | Date | Country | Kind |
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2020902937 | Aug 2020 | AU | national |
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Number | Date | Country | |
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20220054176 A1 | Feb 2022 | US |