# Patent

## Title
Bone anchoring element and stabilization device for bones, in particular for the spinal column

## Abstract

A bone anchoring element includes an anchoring section for anchoring in the bone and a receiving part connected to the anchoring section. The receiving part includes an opening suitable for accommodation of a stabilization rod having a rod axis, the opening being limited along the rod axis by two side walls. The side walls include guides orientated along the rod axis for guiding at least one connection rod therethrough.

## Background
CROSS-REFERENCE TO RELATED APPLICATION(S)
This application is a continuation of U.S. patent application Ser. No. 12/550,654, filed Aug. 31, 2009, which 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.


BACKGROUND
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.
SUMMARY
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.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 shows a side view of the stabilization device according to a first embodiment.
FIG. 2 shows an enlarged sectional view along line A-A in FIG. 1.
FIG. 3 shows an enlarged sectional view along line B-B in FIG. 1.
FIG. 4 shows a top view of the stabilization device of FIG. 1.
FIG. 5 shows a sectional view of the stabilization device of FIG. 4 along line C-C.
FIG. 6 shows a side view of the stabilization device according to a second embodiment.
FIG. 7 shows an enlarged sectional view along line A-A of FIG. 6.
FIG. 8 shows an enlarged sectional view along line B-B of FIG. 6.
FIG. 9 shows a top view of the stabilization device of FIG. 6.
FIG. 10 shows a sectional view along C-C of FIG. 9.
FIG. 11 shows a third embodiment of the stabilization device in a top view.
FIG. 12 shows a side view of the stabilization device of FIG. 11.
FIG. 13 shows a fourth embodiment of the stabilization device in a sectional view along the rod axis.
FIG. 14 shows an enlarged sectional view along line B-B of FIG. 13.
FIG. 15 shows a top view of the stabilization device of FIG. 13.
FIG. 16 shows a side view of the stabilization device of FIG. 15.
FIG. 17 shows a fifth embodiment of the stabilization device in a side view.
FIG. 18 shows an enlarged sectional view along line B-B of FIG. 17.
FIG. 19 shows a top view of the fifth embodiment of the stabilization device.
FIG. 20 shows a sectional view of the stabilization device of FIG. 19 along line A-A.



DETAILED DESCRIPTION
As shown in FIGS. 1 to 5 the bone stabilization device 1 according to a first embodiment includes a flexible rod 2 and at least one laterally arranged connection rod 3 which are both connected to bone anchoring elements 4, 4′.
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 3 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 FIG. 5 the receiving part 43 includes a substantially U-shaped recess 45 extending from the first end 43a in the direction of the second end 43b. By means of the U-shaped recess two free legs 46a, 46b are formed which form together with the bottom of the recess a channel for accommodating the flexible rod 2.
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 FIG. 2 the bores 47a, 47b are located fully within the free legs 46a and 46b and form through holes. The location of the through holes 47a, 47b is such that the bore axis is in one plane with the axis of the flexible rod 2 when the flexible rod 2 is inserted.
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 FIGS. 2 and 3 the cylinder segment-shaped recess 51 is sized such that the flexible rod projects above the pressure element.
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.
FIG. 3 shows a bone anchoring element 4′ which is a modification of the bone anchoring element which is suitable for accommodating the portion 3c of the connection rods shown in FIG. 4. It differs from the bone anchoring element according to FIG. 2 in the construction of the bores 47a′, 47b′. All other elements of the bone anchoring element are the same as those of the bone anchoring element of FIG. 2 and the description thereof will not be repeated. The bores 47a′, 47b′ have a semi-circular cross section. The bores are open to the channel which accommodates the flexible rod 2. The connection rods 3 are secured from inside the receiving part by the flexible rod 2 against falling out from the bores 47a′, 47b′. With this embodiment, it is possible to arrange the connection rods 3 more closely to the flexible rod 2 and the connection rods can be put in place through the U-shaped channel. As particularly shown in FIGS. 1 and 4, with this construction it is possible to span several motion segments of the spinal column with different distances of the flexible rod 2 and the connection rods 3 from each other.
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 FIG. 4, the connection rods can be straight.
With the bone anchoring element shown in FIG. 2, the connection rods are secured within the bores 47a, 47b against escaping. In specific clinical applications it may be possible to use a stabilizing device without the flexible rod.
The bracket 5 shown in FIG. 1 not only serves for connection of the connection rods 3 but also forms a stop for the sliding movement of the connection rods 3. It is also possible to provide a stop at the opposite end at a distance from the anchoring element 4 so that the connection rods 3 are still fully movable.
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.
FIGS. 6 to 10 show a second embodiment of the stabilization device which differs from the first embodiment shown in FIGS. 1 to 5 only by the pressure element 480 compared to the pressure element 48. The pressure element 480 which allows to omit the flexible rod 2 and to provide stabilization only via the connection rods 3. All other elements and parts are identical to the first embodiment and the description thereof will not be repeated.
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 FIGS. 6 to 10, the pressure element 480 can be used instead of the pressure element 48 while all other parts of the first embodiment remaining the same. Hence, the construction of the bone anchoring element with respect to the bores 47a, 47b or 47a′, 47b′ remains the same.
FIGS. 11 and 12 show a third embodiment of the stabilization device which differs from the second embodiment according to FIGS. 6 to 10 only in that the bracket 5 connecting the rods 3 is omitted. In such a case, it is advantageous to provide stops at both ends of the connection rods to allow a free but limited movement of the connecting rods in the receiving parts.
FIGS. 13 to 16 show a fourth embodiment of the stabilization device. In this embodiment a flexible rod 2 and fully straight connection rods 3 are used which are connected by the bracket 5. In this case, the assembly of the connection rods 3 can be introduced in the receiving parts simultaneously by gripping the bracket.
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 FIGS. 17 to 20 has instead of the flexible rod 2 which is a hollow tube with a flexible section, a flexible rod 20 which is made of a flexible plastic material such as an elastomer, for example polyurethane, polycarbonateurethane (PCU) or polysiloxane. The flexible rod 20 exhibits axial flexibility under the action of axial extension or compression. The bone anchoring element 401 is adapted to clamp the flexible rod 20 as can be seen in FIG. 18. The bone anchoring element 401 includes bores 47a, 47b in the wall of the legs as described with respect to the first embodiment and differs from the bone anchoring element of the first embodiment by the shape of the pressure element 402 and the fixation element 404. The pressure element 402 extends above the surface of the flexible rod 20 when the flexible rod 20 is inserted. On the bottom of the recess 51 projections 403 are formed which engage in the surface of the flexible rod 20. The fixation element 404 is a fixation screw as in the first embodiment. However, it has a projection 405 on its lower side facing the flexible rod 20 which engages in the surface structure of the flexible rod 20. By means of this construction the flexible rod 20 is clamped between the pressure element and the fixation screw without blocking the head 42 in the receiving part. The head 42 is locked in its angular position by tightening the fixation screw 404 so that the pressure element presses onto the head.
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.
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.

## Claims

1. A bone anchoring element comprising:
an anchoring section for anchoring to a bone;
a receiving part configured to be pivotably connected to the anchoring section, the receiving part having a first end, a second end, and a generally U-shaped channel extending from the first end towards the second end and forming two legs, wherein each leg has a first side and a second side opposite to the first side along a longitudinal axis of the channel; and
a locking element configured to engage the legs;
wherein the bone anchoring element is adjustable from a first position where the anchoring section and the receiving part are pivotable relative to one another to a second position where an angular orientation between the anchoring section and the receiving part is locked;
wherein each leg defines a substantially straight opening parallel to the longitudinal axis that extends unobstructedly from the first side of the leg to the second side of the leg when the bone anchoring element is at the second position for guiding a connection rod therethrough;
wherein each of the openings is defined by a first portion of the corresponding leg that is directed towards the first end of the receiving part and a second portion of the corresponding leg that is directed towards the second end of the receiving part to restrict movement of an inserted connection rod toward the first and second ends; and
wherein the openings are open to the channel.

2. The bone anchoring element of claim 1, further comprising a securing structure configured to prevent removal of an inserted connection rod from one of the openings.

3. The bone anchoring element of claim 1, wherein the openings are integrally formed in the legs.

4. The bone anchoring element of claim 1, wherein the openings are smaller than an opening defined by free ends of the legs of the receiving part.

5. The bone anchoring element of claim 1, wherein the anchoring section and the receiving part form a polyaxial bone screw.

6. A stabilization system for bones or a spinal column, comprising:
two connection rods; and
two bone anchoring elements, each bone anchoring element comprising:
an anchoring section for anchoring to a bone;
a receiving part configured to be pivotably connected to the anchoring section, the receiving part having a first end, a second end, and a generally U-shaped channel extending from the first end towards the second end and forming two legs, wherein each leg has a first side, a second side opposite to the first side along a longitudinal axis of the channel, and an opening that is parallel to the longitudinal axis and that extends through the leg from the first side of the leg to the second side of the leg; and
a locking element configured to engage the legs to lock an angular orientation between the anchoring section and the receiving part;

wherein each connection rod is configured to be guided through the opening of a corresponding one of the legs of each of the bone anchoring elements to connect the bone anchoring elements to one another.

7. The stabilization system of claim 6, wherein the two connection rods are connectable to each other at one end.

8. The stabilization system of claim 6, further comprising a stabilization rod receivable in the channel, wherein a diameter of each of the connection rods is smaller than a diameter of the stabilization rod.

9. The stabilization system of claim 8, wherein for each bone anchoring element, the locking element is moveable from an unlocked position wherein the stabilization rod is freely movable in the channel to a locked position wherein the stabilization rod is fixed in the channel with the locking element, and wherein the connection rods are freely moveable in the openings in both the unlocked and the locked positions.

10. The stabilization device of claim 6, wherein the two bone anchoring elements comprise polyaxial bone screws, and wherein the connection rods align the receiving parts of the polyaxial bone screws when the connection rods are guided in the openings of the bone anchoring elements.

11. The stabilization system of claim 6, wherein the connection rods are entirely spaced apart in the bone anchoring elements.

12. A method of attaching a stabilization device to bone or vertebra, the stabilization device comprising two connection rods and two bone anchoring elements, each bone anchoring element comprising an anchoring section for anchoring to a bone, a receiving part configured to be pivotably connected to the anchoring section, the receiving part having a first end, a second end, and a generally U-shaped channel extending from the first end towards the second end and forming two legs, wherein each leg has a first side, a second side opposite to the first side along a longitudinal axis of the channel, and an opening that is parallel to the longitudinal axis and that extends through the leg from the first side of the leg to the second side of the leg, and a locking element configured to engage the legs to lock an angular orientation between the anchoring section and the receiving part, the method comprising:
anchoring the anchoring sections of the bone anchoring elements to bone or vertebra;
adjusting respective angular orientations of each of the receiving parts relative to the corresponding anchoring section;
guiding the connection rods through corresponding ones of the openings in the legs of each receiving part; and
inserting respective locking elements in the corresponding receiving part to lock the angular orientation between the receiving part and the corresponding anchoring section.

13. The method of claim 12, further comprising inserting a stabilization rod in the channel of each receiving part.

14. The method of claim 13, wherein the connection rods are guided through the openings of the legs of each receiving part before inserting the stabilization rod in the channel of each receiving part.

15. The method of claim 13, further comprising moving the locking element of each bone anchoring element from an unlocked position wherein the stabilization rod is freely movable in the channel of each receiving part, to a locked position wherein the stabilization rod is fixed in the channel of each receiving part, and wherein the connection rods are freely moveable in the openings in both the unlocked and the locked positions.