The present application relates to a bone anchoring element and to a stabilization device for bones, in particular for the spinal column, including such a bone anchoring element.
In the case of replacement of a severely injured or degenerated intervertebral disc or vertebra by fusion cages or bone segments stabilization devices using rigid metal rods are commonly used which are anchored in the neighboring vertebrae by polyaxial bone screws.
In specific clinical applications it is advantageous to maintain a certain mobility of the motion segments of the spinal column. In these cases, a dynamic stabilization system having bone anchoring elements and flexible rods are used. For example, US 2005/0085815 A1 and US 2007/0049937 A1 describe dynamic stabilization systems having a hollow metallic rod with a flexible section formed by a helix-shaped recess in the wall and a core provided in the hollow rod.
A dynamic stabilization device using polyaxial screws and an elastomer rod is described in EP 1 795 134 A1.
The known stabilization devices with flexible rods are suitable for the dynamic stabilization and motion control of the spinal column with respect to axial tension and compression forces.
Due to the anatomy of the spinal column, small sized implant constructs are required. Therefore, the flexible rods should have small outer diameters which makes it possible to design the receiving part of the polyaxial screw with a low profile and small overall dimensions.
In clinical cases of early degeneration or partial damages or injuries of intervertebral discs, the corresponding motion segments of the spinal column are subject to increased rotational movements and/or increased shearing forces. Such rotational movements and shearing and/or bending forces can cause strong pain. In addition, the flexible rods made of metal or elastomers may not be able to withstand higher forces for a long time due to their small diameter. In particular, shearing and rotational forces may cause an overload of the flexible rod.
Based on the foregoing, there is a need to provide a bone anchoring element and a stabilization device, in particular for the spinal column, which is suitable for cases in which increased rotational and shearing movements of the spinal column are present.
A disclosed bone anchoring element includes a receiving part having a U-shaped recess forming a channel in which a stabilizing rod can be inserted and additionally includes lateral guides for accommodating connection rods with a smaller diameter. A disclosed stabilization device includes at least two such bone anchoring elements and at least one connection rod. The bone anchoring element is preferably a polyaxial bone screw.
The bone anchoring element and the stabilization device has an increased resistance against shearing and rotational forces without hindering the axial damping and the precision adjustment of the stabilization device and it offers a modular system allowing various combinations of flexible rods and connection rods.
As shown in
The flexible rod 2 includes at least a portion 2a exhibiting flexibility under the action of compression and extension forces acting along the rod axis and under the action of torsional, shearing and/or bending forces. In the embodiment shown, the flexible rod 2 is made of a hollow tube of a rigid material, such as a body compatible metal, metal alloy, in particular of titanium, Nitinol, stainless steel or of a rigid body compatible plastic material such as PEEK or carbon fiber reinforced PEEK. The length of the flexible rod is such that it spans at least the distance between two adjacent vertebrae. In the embodiment shown, the flexible rod spans the distance between three adjacent vertebrae. The flexible portion 2a is provided between rigid portions 2b. The rigid portions 2b are connected to the bone anchoring elements. The flexibility of the flexible portion is achieved by a helix-shaped recess in the wall of the hollow tube. However, any other design conferring flexibility to the rod is possible.
At both sides of the flexible rod 2 a solid connection rod 3 is arranged the diameter of which is smaller than that of the flexible rod 2. The length of each of the connection rods 3 can be the same as that of the flexible rod 2 or can be smaller than that of the flexible rod 2. In the embodiment shown, the connection rods 3 are not fully straight, but have a first straight section 3a, a step portion 3b and a second straight section 3c. The connection rods 3 are preferably less flexible when compared to the flexible section 2a of the flexible rod 2. For example, the connection rods 3 are made of a body compatible metal such as stainless steel, titanium, titanium alloys such as Nitinol or a rigid plastic material such as PEEK or carbon reinforced PEEK.
The diameter of the connections rods 3 is considerably smaller than that of the flexible stabilization rod 2. However, the diameter of the connections rods 3 has to have such a size that the connection rods 3 are rigid enough to resist bending forces.
The two lateral connection rods 3 are connected to each other at one of their respective ends by means of a bracket 5 which is formed such that it is orientated downwards or upwards in order to circumvent the flexible rod 2. The bracket 5 can be integrally formed with the rods 3 or can be a separate part which is connectable to the rods 3.
The bone anchoring element 4 is designed in the form of a polyaxial bone screw. It includes a screw element having a threaded shank 41 and spherically shaped head 42 and a receiving part 43 for receiving the flexible rod 2 and the connection rods 3. The receiving part 43 has a substantially cylindrical or cuboid shape with a first end 43a and an opposite second end 43b and a coaxial bore 44 extending from the first end 43a in the direction of the second end 43b and tapering towards the second end such that a seat is provided for the head 42 of the screw element which is pivotably held in the receiving part.
As can be seen in particular in
In the wall of each of the free legs 46a, 46b bores 47a, 47b are provided and which form guides for the connection rods. The bores 47a, 47b extend through the free legs 46a, 46 so that the connection rods 3 can be guided through the bores from one side of the receiving part and exit through the other side. The size of the bores is such that the diameter is slightly larger than the outer diameter of the connection rods 3 to allow a sliding movement of the connection rods 3 within the bores 47a, 47b.
In the embodiment shown in
The polyaxial bone screw further includes a pressure element 48 which is substantially cylindrical so as to be movable in the bore 44 and which has on its side facing the head 42 a spherical recess 49 to encompass a portion of the head to distribute the pressure onto the head 42. It further includes a coaxial bore 50 to allow access to the head 42. On its side opposite to the spherical recess the pressure element 48 has a cylinder segment-shaped recess 51 which is sized such that the flexible rod 2 can be inserted and guided therein. In the embodiment shown in
The bone anchoring element further includes a fixation screw 52 which engages with an inner thread of the free legs 46a, 46b. The fixation screw 52 serves for pressing onto the flexible rod 2 in the receiving part and therefore indirectly pressing onto the pressure element 48 for exerting pressure onto the head 42 to lock the angular position of the screw element with respect to the receiving part.
Although the first embodiment shows that the connection rods 3 can be connected with each other with a integrally formed bracket 5, other possibilities are possible. For example, the connection rods can be mechanically connected at one or at both ends with a connection which is applied after the rods have been introduced into the receiving parts. They must not necessarily be connected, but can be single rods. To avoid that the single rods escape from the receiving parts in the course of their sliding movement, one end of the rods 3 can have a larger diameter which prevents sliding through the guides.
Although the connection rods are shown as cylindrical rods, the cross section of the connection rods may be non-circular, for example oval-shaped, polygon-shaped or otherwise shaped.
Although the outer shape along the rod axis is shown to have a bent portion 3b in
With the bone anchoring element shown in
The bracket 5 shown in
The guides and/or the connection rods can be provided with materials and/or devices for facilitating sliding of the connection rods 3. Such materials and/or devices can be, for example, coating, sliding guides or sliding bearings.
The pressure element 480 has instead of the cylinder segment-shaped recess 51 a cylindrical portion 481 which extends coaxially to the main portion of the pressure element and has a diameter which is smaller than the main portion. The length of the cylindrical portion 481 is such that the pressure element extends up to the fixation screw 52 so that the fixation screw 52 can press the pressure element 480 downwards when it is tightened. This embodiment is particularly suitable for applications where a flexible rod is not necessary. If the stabilization device is used without a flexible rod a shown in
The bone anchoring element 400 of the fourth embodiment differs from the bone anchoring element 4 described in connection with the first embodiment by the location and design of the guides for guiding the connection rods 3. The free legs 46a, 46b have recesses 470a, 470b which are at the outer surface and are open to the outside of the receiving part. The cross section of the recesses 470a, 470b is substantially U-shaped and the size is such that the connection rods 3 can slide therein. To prevent escaping of the rods 3, the free legs 46a, 46b have a support structure 471 supporting a closure element 472, for example a closure bar, which closes the recess 470a, 470b respectively. The recesses 470a, 470b are located at the same height as the bores 47a, 47b of the first embodiment.
All other portions of the bone anchoring element 400 are identical to those of the first embodiment. It shall be noted that the bone anchoring element 400 can also be provided with a pressure element 480 described before when the use of a flexible rod 2 is not necessary.
The stabilization device of a fifth embodiment according to
Although various embodiments have been described in detail the invention is not limited thereto. Single elements of each embodiment can be combined with the other embodiment. In particular, the guides for the connection rods 3 can be varied between the embodiments described. Although specific designs of polyaxial bone screws are described, other designs can also be used, for example polyaxial screws with two part locking elements, polyaxial screws wherein the screw element is loaded into the receiving part from the top or from the bottom, polyaxial screws with various shapes of pressure elements to lock the angular position of the screw element with respect to the receiving part.
Although the embodiments show only polyaxial screws as bone anchoring elements, it is conceivable to provide the guides for the connection rods also in the receiving parts of monoaxial bone screws. However, a dynamic stabilization usually requires the use of polyaxial bone anchoring elements.
In use, first, at least two polyaxial bone anchoring elements are anchored in adjacent vertebral bodies or bone parts. Thereafter, the connection rods are inserted into the guides of the polyaxial bone anchoring elements for aligning the receiving parts with respect to each other in an axial direction. If bone anchoring elements are used which have guides for the connection rods in the form of recesses instead of the through holes the connection rods can be clipped into the recesses by inserting them in the U-shaped channel. This facilitates the step of connecting the bone anchoring elements. Then, the flexible rod is inserted. After insertion of the flexible rod the position and the distance of the bone anchoring elements from each other is adjusted. Finally the flexible rod is fixed by tightening the fixation element. Alternatively, the flexible rod can first be inserted into the U-shaped channels of the bone anchoring elements before guiding the connection rods through the respective guides.
During movements of the motion segments of the spinal column the connection rods 3 can slide within the guides. The connection rods provide resistance against torsional and/or shearing and/or bending forces acting on the stabilization device.
While a particular form of the disclosure has been illustrated and described, it will be apparent that various modifications can be made without departing from the spirit and scope of the disclosure. Accordingly, it is not intended that the disclosure be limited, except as by the appended claims.
Number | Date | Country | Kind |
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08015721 | Sep 2008 | EP | regional |
The present application claims the benefit of U.S. Provisional Patent Application Ser. No. 61/094,664, filed Sep. 5, 2008, the contents of which are hereby incorporated by reference in their entirety, and claims priority from European Patent Application EP 08 015 721.7, filed Sep. 5, 2008, the contents of which are hereby incorporated by reference in their entirety.
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