The invention relates to a bone anchoring device for anchoring a stabilization rod in a bone or in a vertebra, an assembly tool and a method for assembling the bone anchoring device and an insertion tool for use with the bone anchoring device. The bone anchoring device includes an anchoring element, a receiving part for receiving a head of the bone anchoring element and for receiving a stabilization rod to be connected to the anchoring element. The anchoring element is pivotably connected to the receiving part and can be fixed at an angle by exerting pressure onto the head via a pressure element, which is arranged in the receiving part. The pressure element comprises a spring element that engages a portion of the receiving part so that it can be held in a position that allows pivoting of the anchoring element.
U.S. Pat. No. 5,716,356 describes a polyaxial bone screw including a screw element and a receiving part that is pivotably connected to the screw element and a pressure element to exert pressure onto the head of the screw element to fix the angle between the screw element and the receiving part. The receiving part has an U-shaped channel for receiving a stabilization rod. The pressure element comprises a cylindrical recess which is to be aligned with the U-shaped channel to receive the rod therein. In order to hold the pressure element in a position aligned with the U-shaped channel, the position of the pressure element is fixed by crimping through bores provided in the receiving part.
U.S. Pat. No. 5,672,176 describes another example of a polyaxial bone screw with a pressure element that is also held in place by crimp bores without impeding a sufficient movement of the pressure element to clamp the head.
US 2005/0080420 A1 describes a multiaxial bone screw that includes a screw element and a receiver member, a base member for retaining the screw element in the receiver member and a crown element exerting pressure onto the head of the screw element. The crown element comprises a snap-ring to assist in holding the crown element within the receiving part by interfering with a stop surface of the receiving part. The multiaxial bone screw is a so-called bottom loading type screw wherein the screw element is introduced from the bottom into receiving part.
WO 2006/116437 A2 describes a bone anchor for spinal fixation in the form of a polyaxial bone screw including a screw element, a housing, a sleeve and a collet arranged in the housing for exerting pressure onto the head of the screw element. The sleeve has retention tabs that snap into slots in opposite wall positions of the housing.
Usually, the polyaxial bone screws of the above-described type are delivered, for example by the manufacturer, in a pre-assembled condition. In this condition a specific screw element, e.g. a screw element having a specific length and shaft diameter or a specific thread form, is connected to a receiving part and the pressure element is arranged therein so that it cannot escape. For the surgery, the necessary number and types of such pre-assembled polyaxial bone screws are selected and provided in advance as a full set of implants.
It is the object of the invention to provide a bone anchoring device, an assembly tool and a method of assembling the same and an insertion tool for use with the same which can be handled in a simple manner at the operation site or anywhere by the surgeon or other personnel.
The bone anchoring device has only a few parts. The parts are of a simple design. This provides for a lower cost of manufacturing and a convenient handling without sophisticated tools or machinery. It is possible to assemble the bone anchoring device by hand in any condition of the delivery after the parts have been manufactured and before the screw element is inserted into the bone. Therefore, the assembling of the polyaxial bone screw can be carried out by anybody, in particular by the surgeon or any personnel assisting him before or during surgery.
With the bone anchoring device, a modular system can be provided to allow the combination of various anchoring elements with any suitable receiver on demand, depending on the actual clinical requirements. This reduces the cost of polyaxial screws, reduces the inventory and gives the surgeon a substantial choice of implants. In addition, existing receiving parts may be upgraded with the pressure element to form the bone anchoring device according to the invention.
The assembly tool is simple and its function and handling is immediately apparent to the user. The correct mounting of the pressure element is easily recognizable. The insertion tool to be used for inserting the bone anchoring device permits a safe handling of the bone anchoring device during surgery.
Further features and advantages of the invention will become apparent from the description of embodiments by means of the accompanying drawings.
a) to c) show a side view, a side view rotated by 90° and a sectional view, respectively, of the pressure element of bone anchoring device according to the first embodiment.
a) to c) show a side view, a side view rotated by 90° and sectional view, respectively, of a pressure element according to a second embodiment of the bone anchoring device.
a) to c) show a side view, a side view rotated by 90° and a sectional view, respectively, of a pressure element of a third embodiment of the bone anchoring device.
a) to c) show a side view, side view rotated by 90° and a sectional view, respectively, of the pressure element of a fourth embodiment of the bone anchoring device.
a) to h) show steps of assembling the bone anchoring device using the tool for assembling the bone anchoring device, each step in a side view and a side view rotated by 90°, respectively.
The bone anchoring device 1 according to a first embodiment shown in
The receiving part 5 as shown in particular in
The pressure element 6 according to the first embodiment as particularly shown in
The pressure element further comprises on the outer wall portion of each of the legs 63, 64 a spring element 66, 66′ with a detent portion 67, 67′ that cooperates with the receiving part 5, in particular with the bore 58, 59. The spring element 66, 66′ is formed by means of a slot 69, 69′ which is closed at the top and at the bottom and which extends completely through the legs 63, 64 in a direction parallel to the longitudinal axis of the channel, thereby leaving a portion of each leg 63, 64 spaced apart from the main body of the pressure element 6. At the outer wall of the spring element 66, 66′, the detent portion 67, 67′ is provided, which projects outward in such a way that the outer diameter of the pressure element 6 at the detent portion 67, 67′ is larger than the inner diameter of the bore 53 of the receiving part 5. The overall size of the slot is larger than the cross-section of the bores 58, 59 in the receiving part. The depth and the overall size of the slot is such that the spring element 66, 66′ can be moved resiliently into the space provided by the slot to such an extent, that the detent portion 67, 67′ can be immersed therein. As can be seen in particular in
Finally, the pressure element 6 has a coaxial bore 6a extending through it to allow access to the head 4 by a tool.
As shown in
The parts of the bone anchoring device are all made of a body compatible material such as titanium or stainless steel, a body compatible metal alloy, for example a Ti—Ni alloy, or a body compatible plastic material, such as PEEK. In particular, the pressure element 6 can be made of a body compatible plastic material which allows an easy manufacture and a safe function of the spring element.
A second embodiment of the bone anchoring device will be described with reference to
A third embodiment of the bone anchoring device will be described with reference to
A fourth embodiment of the bone anchoring device will be described with reference to
Features of the different pressure elements described in
Next, a tool for assembling the bone anchoring device and assembling steps are shown with reference to
In step 1, first, as shown in
If a pressure element with a symmetric detent is used as described before, the pressure element can be removed from the pre-assembled position by pressing it out of the receiving part with the screw element.
Hence, the surgeon or any other person can easily preassemble a suitable combination of an anchoring element and a receiving part on demand and on-site.
Next, a tool for inserting the bone anchoring device into the bone and the use thereof is described with reference to
In use, after assembly of the bone anchoring device 1, the receiving part 5 is engaged with the counter-holding member 102 and the drive member 101 is connected to the recess 4′ of the head 4. Then, the screw element 2 is inserted into the bone. Thereafter, the tool 100 is removed and the receiving part 5 is pivoted until it has the correct orientation to take up the rod 20. The rod 20, which connects several bone anchoring devices, is inserted and the outer screw 7 of the locking device is tightened on each bone anchoring device to move each pressure element 6 downward to clamp each head 4. The rod 20 is then fixed by the inner screw 8 of each locking device.
For the anchoring element all kinds of anchoring elements can be used and combined with a receiving part. These anchoring elements are e.g. screws of different length, with different diameters, cannulated screws, screws with different thread forms, nails, etc.
All kinds of receiving parts can be used in particular such with different locking devices, e.g. one part locking devices such as a single set screw that locks the rod and the head simultaneously, outer nuts, outer caps, bayonet locking devices or others. The engagement recesses for the spring elements of the pressure element need not to go through the wall completely but can be provided at the inner wall only. The shape of the receiving part is not limited to the embodiment shown. For example, the receiving part can have an asymmetric end portion for allowing a greater pivot angle of the screw member to one side.
The shape of the pressure element is also not limited to the embodiments shown. Only by way of example, the pressure element can be constructed so as to exert the pressure onto the head from the side of the head, e.g. via a conically tapering portion and/or can have a slotted portion clamping the head or other shapes.
Modifications of the tools described above are also conceivable. For example, the assembling tool can be constructed so as to clamp the pressure element.
| Number | Date | Country | Kind |
|---|---|---|---|
| 09168328 | Aug 2009 | EP | regional |
This application claims priority to and the benefit of U.S. Provisional Patent Application Ser. No. 61/235,493, filed Aug. 20, 2009, and claims priority from European Patent Application Number EP09168328.4, filed Aug. 20, 2009, the entire contents of which are both incorporated herein by reference.
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