The present invention relates to a bone fixation device. More particularly, but not exclusively, the present invention relates to a bone fixation device comprising first and second screw receiving members connected together by a relatively pliable connecting arm adapted to bend before the screw receiving members.

Bone fixation plates are known. Such plates typically comprise a plastically deformable plate such as a metal plate. A plurality of apertures extend through the plate. In use the plate is positioned against a bone and screws passed through the apertures to fix the plate to the bone.

In order to ensure a close fit between the plate and the bone it is often necessary to deform the plate slightly. Deforming the plate distorts the apertures, this reduces the accuracy of the fit between plate and screws and may allow the plate to move relative to the bone during use.

A further bone fixation device is disclosed in PCT/US2005/020157. Such a device comprises a number substantially spherical screw receiving members having screws extending therethrough. Extending from each screw receiving member is a connecting member. A connecting arm, rather than extending along a long axis between the screw receiving members, extends to the side of the long axis. The screw receiving members are connected to the connecting arm by the connection members. Such a construction has a number of drawbacks. It is complex having a number of parts which must be assembled in a multistep procedure. In addition, one cannot simply twist the device about the long axis as is often required.

The device according to the invention seeks to overcome these problems.

Accordingly, the present invention provides a bone fixation device comprising

first and second screw receiving members, each member having an aperture extending therethrough for receiving a screw; and

a plastically deformable connecting arm extending between the screw receiving members along a long axis defined by the first and second screw receiving members;

the arm being adapted to be more pliable than the screw receiving members such that (a) on twisting the device about its long axis the arm twists before the screw receiving members deform; and (b) on bending the device along its long axis the arm bends before the screw receiving members deform.

The device according to the invention can be attached by a simplified procedure whereby it is deformed to the correct shape without deforming the apertures, placed against the bone and then screwed in place. In addition, it can be both bent along its long axis and twisted about its long axis to correctly align the device with the bone to the patient.

The device according to the invention is deformed to fit a bone the connecting arm(s) will deform before the screw receiving members. This allows the device to be deformed to the correct shape without the apertures becoming distorted.

Preferably, the device comprises a plurality of screw receiving members connected together in a line by connecting arms.

Preferably, at least one connecting arm is cylindrical in cross section.

At least one screw receiving member can be substantially spherical.

Preferably, a portion of the spherical member is flattened.

The flattened part can be centered about a mouth of the aperture and is in a plane normal to the axis of the aperture.

Preferably, a part of at least one aperture is threaded for receiving a screw.

Preferably, the aperture is cylindrical.

The cross section of the cylindrical aperture can be constant along its length.

Preferably, the device further comprises at least one screw adapted for threaded engagement with the threaded portion of the aperture, the screw having a tapered head adapted to be drawn into the aperture and to press fit with the walls of the aperture on threading the screw into engagement with the threaded portions of the aperture.

Alternatively, the cylindrical aperture has at least one step and cross section along its length to define a lip for engagement with a tapered head of a screw.

In a further aspect of the invention there is provided a method of connecting a bone fixation device to a bone comprising the steps of

(a) providing a bone fixation device comprising

first and second screw receiving members, each member having an aperture extending therethrough for receiving a screw; and

a plastically deformable connecting arm extending between the screw receiving members along a long axis defined by the first and second screw receiving members;

the arm being adapted to be more pliable than the screw receiving members such (a) on twisting the device about its long axis the arm twists before the screw receiving members deform; and (b) on bending the device along its long axis the arm bends before the screw receiving members.

(b) deforming the bone fixation device to the profile of the bone; and,

(c) screwing the bone fixation device to the bone by means of screws inserted through the apertures on the screw receiving members.

The present invention will now be described by way of example only and not in any limitative sense with reference to the accompanying drawings in which

Figure 1 shows a known fixation plate before and after deformation;

Figure 2 shows a further known bone fixation device in perspective view;

Figure 3 shows a bone fixation device according to the invention in perspective view;

Figure 4 shows the embodiment of Figure 3 in combination with a screw;

Figure 5 shows a further embodiment of a bone fixation device according to the invention in cross sectional view; and

Figure 6 shows the embodiment of Figure 5 after twisting.

Shown in Figure 1 is a known bone plate 1. The bone plate 1 comprises a metal plate 2 having a plurality of apertures 3. In use the bone plate 1 is placed against a bone (not shown). Bone fixation screws (not shown) are passed through the apertures 3 and then screwed into the bone. The screw heads typically engage with the plate 1 firmly fixing the plate 1 in position and preventing it from being displaced with respect to the bone.

A problem can arise however if the bone plate 1 needs to be deformed before it can be fixed to the bone. Deformation of the plate 1 deforms the apertures 3 in the plate 1 as shown. This prevents the screw heads from accurately engaging with the apertures 3 which may result in the plate 1 being free to wobble slightly with respect to the bone. This can reduce the effectiveness of the bone plate 1 as a support for the bone.

In addition, it can be difficult to remove such a known bone plate 1 from the bone when it is no longer required. The screw heads tend to cold weld to the bone plate 1 over time making the screws difficult to remove. It is often necessary to cut the bone plate 1 free which can result in damage to the bone.

Such a known bone plate 1 is also limited as to how it can be deformed. Whilst the plate 1 can be bent as shown in Figure 1 it is not a simple matter to twist it such that the apertures 3 lie in different planes.

Shown in Figure 2 is a further known bone fixation device 4. This device 4 comprises a plurality of substantially spherical screw receiving members 5. Extending from each screw receiving member 5 is a connecting member 6. A connecting arm 7 extends through the connecting members 6 connecting the screw receiving members 5 together.

In use the screw receiving members 5 are arranged in the correct position and screwed to the bone. The connecting arm 7 is then passed through the connecting members 6 to complete the device 4.

Such a device 4 overcomes the problem of deformation of the screw receiving members by separating the screw receiving members 5 from the connecting arm 7 to be deformed. This separation however increases the complexity of the device 4 and the installation procedure. The connecting arm 7 needs to be deformed to a complex shape before it can be threaded through the connecting members 6. The threading can be difficult or even impossible in a confined space. Because of the gap between the screw receiving members 5 and the connecting arm 7 the device 4 is unsuitable for use where a longitudinal twist of the device 4 is required.

Shown in Figure 3 is a bone fixation device 8 according to the invention. The device comprises a plurality of screw receiving members 9. Apertures 10 extend through each of the screw receiving members 9 for receiving screws. A long axis 11 extends between each of the screw receiving members 9. Plastically deformable connecting arms 12 extend along the long axis 11 between the screw receiving members 9 as shown. In this embodiment the long axis 11 passes through the apertures 10 of the screw receiving members 9.

In use the bone fixation device 8 is gripped and bent to the required shape. The arms 12 are more pliable than the screw receiving members 9 and accordingly it is the arms 12 that bend when the force is applied, rather than the screw receiving members 9.

The apertures 10 therefore remain undistorted. In addition, in contrast to known bone plates 1 a torsional (twisting) force can be applied to the device 8 rotating one or more of the screw receiving members 9 about the long axis 11 of the device 8 if required. As the long axis 11 passes along the length of the connecting arm 12 the connecting arm 12 twists about its length. The device 8 can therefore be twisted without significantly altering its dimensions. The device 8 can therefore be inserted into small apertures even after twisting.

In this embodiment of the invention each of the screw receiving members 9 is substantially spherical with the apertures 10 extending through the centres of the spheres 9. Each aperture 10 intersect the sphere at mouths 13 on opposite sides of the sphere 9. The sphere 9 comprises a slightly flattened portion 14 around one of the mouths. This reduces the profile of the device 8. It also provides an extended contact area between the screw receiving members 9 and the bone (not shown).

The connecting arms 12 between the screw receiving members 9 are cylindrical. The interface 15 between the arms 12 and spherical screw receiving members 9 is chamfered so that any bending or torsional forces do not concentrate at this interface 15.

The ends 16 of the device 8 are tapered as shown so that the device 8 can be placed between bone and soft tissue without surgically exposing the entire length of bone.

Each of the apertures 10 of this embodiment is cylindrical having a constant area along its length. A portion of the aperture 10 is threaded. The remainder of the aperture 10 is smooth walled.

After bending and/or twisting to the correct shape the device 8 is positioned against the bone. Screws (not shown) are inserted into the apertures 10 through the smooth portions and into threaded engagement with the threaded portions. On further rotation of the screws they penetrate and grip the bone, fixing the device 8 to the bone. A significant advantage of the device 8 is that it can be bent/twisted to the correct shape, positioned correctly and then screws inserted. This considerably simplifies the attachment procedure. As the screw receiving members 9 are aligned with the

connection arms 12 along the long axis 11 the device 8 can be twisted about its length without any significant change in dimensions of the device 8. This is particularly useful when inserting the device 8 into small apertures.

The device 8 is adapted to be used with a screw (not shown) having two portions - a threaded portion for gripping the threaded portion of the aperture 10 and then the bone and a smooth portion extending from the threaded portion . The smooth portion has an outer face which is substantially cylindrical and of the same diameter as the threaded portion. The smooth portion is however slightly tapered with its diameter increasing in a direction away from the threaded portion. At its end the diameter of the smooth portion is slightly larger than the diameter of the aperture 10. As the screw is turned and is drawn into the aperture 10 the smooth portion of the screw abuts the smooth portion of the aperture 10 so producing a press fit.

An alternative embodiment of the invention is shown in Figure 4. In this embodiment the threaded portion of the aperture 10 is narrower in diameter than the smooth portion. The screw 17 has a narrow threaded portion 18 and a wider smooth tapered head portion 19 as shown. The narrow threaded portion 18 of the screw 17 engages with the narrow portion of the aperture 10 drawing the larger smooth head portion 19 into abutment with the smooth portion of the aperture 10.

The embodiment of Figure 4 can be used with an alternative design of screw (not shown). The alternative design comprises a threaded shaft having a domed head extending away from the shaft. As the screw is drawn into the aperture 10 the domed head abuts the lip formed by the change in diameter of the aperture 10.

In a further embodiment of the invention (not shown) both the narrow and wide portions of the aperture 10 are threaded. Similarly, the screw comprises a narrow threaded shaft and a larger diameter threaded head. In use the threaded head engages with the larger portion of the aperture 10.

In a further embodiment of the invention (not shown) a portion of the aperture 10 is slightly bevelled so that a standard bone screw head will press fit into engagement with the bevels as the screw is drawn into the aperture 10.

Shown in Figure 5 in cross sectional view is a further embodiment of a device 8 according to the invention. The aperture 10 comprises a first narrow threaded section 20. Extending from this is a second smooth walled section 21 of larger diameter. Extending from the second section 21 is a third smooth walled section 22 of slightly larger diameter then the second section 21. The step change in diameter from the second section 21 to the third section 22 defines a lip 23. In use a screw 24 is inserted into the aperture 10 with the threaded portion 25 of the screw 24 in threaded engagement with the narrower portion 21 of the aperture 10. As the screw 24 is turned and drawn into the aperture 10 the head 26 of the screw 24 abuts the Hp 23 producing a tight fit.

Shown in Figure 6 is the embodiment of Figure 5 in perspective view. The device 8 has been twisted along its length such that the apertures 10 lie in different planes. As can be seen, the arms 12 have twisted before the screw receiving members 9 deform.

In a further embodiment of the invention the screw receiving members 9 are substantially elliptical.

The device 8 according to the invention can be used with any tool which grips the screw receiving members 9. One preferred embodiment of such a tool comprises jaws having cut out sections which match the spherical component of the screw receiving members 9. The tool also has cut outs which match the interface 15 between the spherical component 9 and connecting arm 12 so that the tool can apply a bending force throughout the length of the bone fixation device 8. In an alternative embodiment the jaws have cut outs which match the flattened portions 14 of the screw receiving members 9.

In use two of the tools are used to grip the screw receiving members 9. The device 8 is then bent and/or twisted to the desired shape and then released.